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VERSANT HCV RNA 3.0 ASSAY (BDNA)

Received Oct 28, 2010 · Event occurred Oct 7, 2010

Report 3003932969-2010-00003 · MDR key 1890873

Device

Generic name

Versant Hcv Rna 3.0 Assay (bdna)

Model number

NA

Catalog number

02553870

Lot number

KIT LOT C040

Product problems

  • Incorrect Or Inadequate Test Results

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Description of Event or Problem

THIRTEEN DISCREPANT HCV PT VALUES WERE REPORTED TO PHYSICIANS. A PHYSICIAN QUESTIONED THE RESULTS AND RETESTS WERE PERFORMED. PT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative

ADDITIONAL CATALOG #: 02554338. RESULTS OF SAMPLES, WHICH WERE TESTED INITIALLY ON (B)(6) 2010. SAMPLES WERE RETESTED ON (B)(6) 2010, AND THEN A FINAL CONFIRMATORY RUN WAS DONE. SAMPLE CARRYOVER WAS RULED OUT. THE ROOT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED BUT IS THOUGHT TO BE A SAMPLE HANDLING ERROR BY THE OPERATOR. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

Remedial action

  • Notification