TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 303 ANALYZER IS (B)(6). UPON REVIEW OF THE ALARM TRACE, MULTIPLE ABNORMAL ASPIRATION ALARMS WERE OBSERVED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 10.9 %. THE VALUE WAS QUESTIONED BY A PHYSICIAN AS THE RESULT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL STATE. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN AN HBA1C VALUE OF 5.09 %.

Additional Manufacturer Narrative

THE CUSTOMER STATED THEY RECEIVED QUESTIONABLE HBA1C RESULTS FOR A SECOND PATIENT SAMPLE TESTED ON (B)(6) 2024. THIS SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 14.5 %. A PHYSICIAN QUESTIONED THE RESULT. WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 5.48 %. UPON REVIEW OF THE ALARM TRACE, MANY ABNORMAL ASPIRATION ERRORS WERE OBSERVED. THESE ALARMS MAY INDICATE ISSUES WITH SAMPLE QUALITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

FOR THE SECOND PATIENT SAMPLE, THE REPEAT HBA1C RESULT OF 5.48 % WAS DEEMED CORRECT AS IT MATCHED THE PATIENT'S HISTORY.