BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III ERRONEOUS RESULTS WERE OBTAINED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE SPA IS NOT ADDING REAGENT TO THE SAMPLE TUBE. A FULL RACK OF SAMPLES WAS PREPPED, THE FIRST 12 LOOKED AND RAN FINE, BUT THE REMAINING 28 DID NOT HAVE ANY REAGENTS IN THEM (ERRONEOUS RESULTS). THEY DISCARDED THE AFFECTED SAMPLES AND PREPPED THE PRIMARY SAMPLES AGAIN ON ANOTHER SPA WHERE THEY PROCESSED SUCCESSFULLY. SAMPLES WERE IMPROPERLY PREPARED BY THE SPA AND WHEN THEY WERE RUN ON THE CYTOMETER THEY PRODUCED ERRONEOUS PATIENT RESULTS, WHICH WERE NOTICED BY THE LAB TECHNICIANS WHO DISCARDED THE SAMPLES AND RE-PREPPED NEW ONES ON ANOTHER SPA.

Additional Manufacturer Narrative

D2A: COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). ANNEX B, C, AND D CODES: B21, C21, D16.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III ERRONEOUS RESULTS WERE OBTAINED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE SPA IS NOT ADDING REAGENT TO THE SAMPLE TUBE. A FULL RACK OF SAMPLES WAS PREPPED, THE FIRST 12 LOOKED AND RAN FINE, BUT THE REMAINING 28 DID NOT HAVE ANY REAGENTS IN THEM (ERRONEOUS RESULTS). THEY DISCARDED THE AFFECTED SAMPLES AND PREPPED THE PRIMARY SAMPLES AGAIN ON ANOTHER SPA WHERE THEY PROCESSED SUCCESSFULLY. SAMPLES WERE IMPROPERLY PREPARED BY THE SPA AND WHEN THEY WERE RUN ON THE CYTOMETER THEY PRODUCED ERRONEOUS PATIENT RESULTS, WHICH WERE NOTICED BY THE LAB TECHNICIANS WHO DISCARDED THE SAMPLES AND RE-PREPPED NEW ONES ON ANOTHER SPA.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE ¿THE SPA IS NOT ADDING REAGENT TO THE SAMPLE TUBE¿ WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DEVICE HISTORY RECORD (DHR) REVIEW AND COMPLAINT HISTORY REVIEW. SPA SAMPLE PREPARATION WAS NOT PERFORMING PROPERLY DUE TO LIQUID LEVEL SENSOR UNABLE TO DETECT FLUID. NEW TUBES AND SAMPLES WERE RUN WITH NO ERRORS. LIQUID LEVEL SENSOR WAS REPLACED (CUSTOMER SUPPLIED PART) AND PASSED A&P TESTS. ERROR APPEARS TO HAVE BEEN A CAUSE OF OLD TEST TUBES BEING USED AND AIR IN THE LINE. NO ACTUAL ERRONEOUS RESULTS WERE REPORTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III ERRONEOUS RESULTS WERE OBTAINED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE SPA IS NOT ADDING REAGENT TO THE SAMPLE TUBE. A FULL RACK OF SAMPLES WAS PREPPED, THE FIRST 12 LOOKED AND RAN FINE, BUT THE REMAINING 28 DID NOT HAVE ANY REAGENTS IN THEM (ERRONEOUS RESULTS). THEY DISCARDED THE AFFECTED SAMPLES AND PREPPED THE PRIMARY SAMPLES AGAIN ON ANOTHER SPA WHERE THEY PROCESSED SUCCESSFULLY. SAMPLES WERE IMPROPERLY PREPARED BY THE SPA AND WHEN THEY WERE RUN ON THE CYTOMETER THEY PRODUCED ERRONEOUS PATIENT RESULTS, WHICH WERE NOTICED BY THE LAB TECHNICIANS WHO DISCARDED THE SAMPLES AND RE-PREPPED NEW ONES ON ANOTHER SPA.