BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST

    MDR report key: 12823964 · Received November 16, 2021

    Report

    Report Number
    3008352382-2021-00185
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 21, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MLA
    UDI-DI
    00382904462574
    PMA / PMN Number
    K931374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: QUALITY INITIATED AN INVESTIGATION ON NEGATIVE RESULTS ¿ IMPROPER PROCESSING CUSTOMER CLAIM ON MATERIAL 446252, BATCH 1222584. BATCH HISTORY RECORD REVIEW WAS PERFORMED TO THE FINISHED PRODUCT, NO DEVIATION WAS REPORTED ON THE RECORD. IN-PROCESS AND QC TESTING WERE WITHIN SPECIFICATIONS. FUNCTIONAL TEST WAS PERFORMED TO THE RETENTION SAMPLE USING A, B AND C DILUTIONS WITH SATISFACTORY RESULTS. A WHOLE CELL TEST WAS PERFORMED TO THE RETENTION SAMPLE WITH SATISFACTORY RESULTS. VISUAL INSPECTION WAS PERFORMED TO THE RETENTION SAMPLE WITH SATISFACTORY RESULTS. NO RETURNED GOODS SAMPLE WAS AVAILABLE. BD CAYEY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH NEGATIVE RESULTS. COMPLAINT UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST APPROXIMATELY 82 FALSE NEGATIVES WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED BY RECOLLECTING AND RETESTING THE SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TOO MANY NEG RESULTS SPOKE TO QUALITY AND CALLED TO FOLLOW UP WITH THE CUSTOMER - THEY ARE RECOLLECTING 82 SAMPLES FOR REPEAT RUNS. CUSTOMER IS ALSO RUNNING ANOTHER 250 SAMPLES TODAY, AND WILL KEEP ME POSTED ON THEIR PROGRESS. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: (B)(6). INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): CLINICAL SINCE WE MAY SAFELY EXCLUDE THE FOLLOWING FACTORS: INSTRUMENT(S), COLLECTION, REAGENTS, LYSIS BLOCK, ENVIRONMENTAL FACTORS, SUGGESTED THAT THE LYSIS AND BUFFER BOTTLES GOT MIXED UP IN THE PROCESS. THAT WOULD EXPLAIN THE WORKING IC AND NEG RESULTS FOR ALL SAMPLES / ALL TARGETS AS THE SAMPLES NEVER GOT PROCESSED PROPERLY (NO LYSIS AT 85 C STEP). (CUSTOMER WILL TRY TO RECOVER ONE PATIENT SAMPLE FROM ANY CASSETTE, AND PUT IT ON LYSIS BLOCK FOR 10 MINUTES, THEN PROCESS). EXPLAINED TO THE CUSTOMER THAT THIS PROCESS WILL BE OUTSIDE OUR CLAIMS, AND SHOULD ONLY BE TRIED AS AN "IMPROVISED" TROUBLESHOOTING TO CHECK THE BOTTLES SWITCH THEORY. THEN, TO BE REPORTED, ALL SAMPLES FROM 174 TO 300 WILL HAVE TO BE RE-COLLECTED AND REPEATED. CUSTOMER PROBLEM: AFF 446257_1222584 TOO MANY NEG RESULTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER INITIALLY STATED THEY ARE USING THE 24-SAMPLE KIT 446252. 300 PATIENT SAMPLES WERE RAN TODAY ON 6 MICROPROBE INSTRUMENTS; SAMPLES WERE COLLECTED ON MANY DIFFERENT SITES; FIRST 173 SAMPLES HAD NO ISSUES, BUT BEGINNING WITH SAMPLE 174, ALL RESULTS WERE NEG FOR ALL THREE TARGETS, WHICH - PER CUSTOMER - IS A VERY UNUSUAL; INTERNAL CONTROL ON ALL PACS WORKED AS EXPECTED; EXTERNAL QC PASSED; THE NEG RESULTS IN QUESTION WERE PRODUCED ON ALL 6 INSTRUMENTS SIMULTANEOUSLY; REAGENTS KIT 446257 LOT # 1222584 (EXP. 2022/06/07) WAS THE ONLY ONE THAT WAS IN USE TODAY; THE TECHNICIAN IS VERY EXPERIENCED, AND HE HAD A TRAINEE TODAY, WORKING WITH THE TECHNICIAN, UNDER HIS SUPERVISION; LYSIS BLOCK IS AND WAS ALL DAY AT 85 C; THERMOMETER IS CALIBRATED; LAB TEMPERATURE IS AMBIENT, NO A/C IS AFFECTING THE TESTING PROCESS; SAMPLE 173 AND 174 BELONGED TO THE SAME COLLECTION SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST APPROXIMATELY 82 FALSE NEGATIVES WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED BY RECOLLECTING AND RETESTING THE SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TOO MANY NEG RESULTS SPOKE TO QUALITY AND CALLED TO FOLLOW UP WITH THE CUSTOMER - THEY ARE RECOLLECTING 82 SAMPLES FOR REPEAT RUNS. CUSTOMER IS ALSO RUNNING ANOTHER 250 SAMPLES TODAY, AND WILL KEEP ME POSTED ON THEIR PROGRESS. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: (B)(4). INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): CLINICAL SINCE WE MAY SAFELY EXCLUDE THE FOLLOWING FACTORS: INSTRUMENT(S), COLLECTION, REAGENTS, LYSIS BLOCK, ENVIRONMENTAL FACTORS, SUGGESTED THAT THE LYSIS AND BUFFER BOTTLES GOT MIXED UP IN THE PROCESS. THAT WOULD EXPLAIN THE WORKING IC AND NEG RESULTS FOR ALL SAMPLES / ALL TARGETS AS THE SAMPLES NEVER GOT PROCESSED PROPERLY (NO LYSIS AT 85 C STEP). (CUSTOMER WILL TRY TO RECOVER ONE PATIENT SAMPLE FROM ANY CASSETTE, AND PUT IT ON LYSIS BLOCK FOR 10 MINUTES, THEN PROCESS). EXPLAINED TO THE CUSTOMER THAT THIS PROCESS WILL BE OUTSIDE OUR CLAIMS, AND SHOULD ONLY BE TRIED AS AN "IMPROVISED" TROUBLESHOOTING TO CHECK THE BOTTLES SWITCH THEORY. THEN, TO BE REPORTED, ALL SAMPLES FROM 174 TO 300 WILL HAVE TO BE RE-COLLECTED AND REPEATED. CUSTOMER PROBLEM: (B)(4) TOO MANY NEG RESULTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER INITIALLY STATED THEY ARE USING THE 24-SAMPLE KIT 446252 300 PATIENT SAMPLES WERE RAN TODAY ON 6 MICROPROBE INSTRUMENTS; SAMPLES WERE COLLECTED ON MANY DIFFERENT SITES; FIRST 173 SAMPLES HAD NO ISSUES, BUT BEGINNING WITH SAMPLE 174, ALL RESULTS WERE NEG FOR ALL THREE TARGETS, WHICH - PER CUSTOMER - IS A VERY UNUSUAL; INTERNAL CONTROL ON ALL PACS WORKED AS EXPECTED; EXTERNAL QC PASSED; THE NEG RESULTS IN QUESTION WERE PRODUCED ON ALL 6 INSTRUMENTS SIMULTANEOUSLY; REAGENTS KIT 446257 LOT # 1222584 (EXP. 2022/06/07) WAS THE ONLY ONE THAT WAS IN USE TODAY; THE TECHNICIAN IS VERY EXPERIENCED, AND HE HAD A TRAINEE TODAY, WORKING WITH THE TECHNICIAN, UNDER HIS SUPERVISION; LYSIS BLOCK IS AND WAS ALL DAY AT 85 C; THERMOMETER IS CALIBRATED; LAB TEMPERATURE IS AMBIENT, NO A/C IS AFFECTING THE TESTING PROCESS; SAMPLE 173 AND 174 BELONGED TO THE SAME COLLECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717748 BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST DNA PROBE, YEAST MLA BECTON DICKINSON CARIBE LTD. 446257 1222584 00382904462574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown