BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11960318 · Received June 8, 2021

    Report

    Report Number
    1119779-2021-00958
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 4, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD SARS-COV-2 REAGENTS (REF. (B)(4) ) FROM 16 LOTS: 0182255, 0233783, 0240506, 0274382, 0274398, 0290223, 0302002, 0302996, 0338462, 0338473, 0353952, 1012622, 1012624, 1039514, 1068080 AND 1074032 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. THE LOTS INITIALLY MENTIONED IN THE COMPLAINT WERE ERRONEOUS AND INVESTIGATED LOTS WERE FOUND WITH THE LIST PROVIDED BY THE CUSTOMER WITH THE SUSPECTED N1 WEAK POSITIVE SAMPLES AND THE DATABASE FROM INSTRUMENT CT1945. ALSO, IT WAS IDENTIFIED THAT THE SAME SAMPLES FROM KIT LOT 1026931 AND 1026936 FROM INSTRUMENT CT1945 HAD ALREADY BEEN INVESTIGATED UNDER 4 OTHER COMPLAINT INVESTIGATIONS ((B)(4)) AND THEREFORE, WERE NOT INVESTIGATED IN THIS COMPLAINT. REVIEW OF THE MANUFACTURING RECORDS OF BD SARS-COV-2 REAGENTS INDICATED THAT ALL LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE COMPLAINT CONCERNS SUSPECTED WEAK POSITIVE RESULTS FOR N1 GENE WITH MULTIPLE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT LOT NUMBERS THAT WERE NEGATIVE UPON RETEST ON THE BD MAX PLATFORM. DATABASE OF INSTRUMENT CT1945 AND A TABLE CONTAINING A LIST OF 69 SUSPECTED WEAK POSITIVE RESULT WERE PROVIDED FOR INVESTIGATION. FROM THESE SUSPECTED DISCREPANT RESULTS, ONLY 61 WERE INVESTIGATED SINCE SAMPLE B02 FROM RUN 508 WAS FROM AN INCOMPLETE RUN AND SAMPLES FROM RUNS 415 (A5), 417(B7), 423(A5, A11, B3), 424(B4) AND 488(A6) HAVE ALREADY BEEN INVESTIGATED UNDER 4 OTHER INVESTIGATIONS ((B)(4)). THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL VALID SAMPLES. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. EXAMINATION OF THE PCR CURVES REVEALED TWO DIFFERENT PATTERNS. THE FIRST CURVE PATTERN CONCERNS 5 SAMPLES: RUN 86 SAMPLE A10, RUN 98 SAMPLE B9, 531 SAMPLE A9, RUN 557 SAMPLE B4 AND RUN 558 SAMPLE B6. CORRESPONDING CURVES SHOWED ABERRANT CURVE GEOMETRY WITH STEP DISLOCATIONS IN THE RAW PCR SIGNAL. THESE STEP DISLOCATIONS CAUSED SHIFTS IN THE DETECTED FLUORESCENCE, WHICH CROSSED THE THRESHOLD AND GAVE A POSITIVE RESULT SUGGESTING A POTENTIAL CONTRIBUTION OF INSTRUMENT TO WHAT WAS OBSERVED BY THE CUSTOMER. BD INSTRUMENT QUALITY ENGINEER ALSO REVIEWED THE DATA AND CONFIRMED THE NEED TO OPEN AN INSTRUMENT SERVICE TICKET TO ASSESS A POTENTIAL NORMALIZER DRIFT ON THE INSTRUMENT CT1945. THE SECOND CURVE PATTERN CONCERNS ALL 56 OTHER SAMPLES. THE OVERALL SHAPE OF THE CURVES, AS WELL AS CT VALUES AND ENDPOINT RESULTS, SUGGEST LOW BUT TRUE AMPLIFICATIONS. OVERALL, THESE SAMPLES APPEAR TO BE TRUE LOW POSITIVES, WHICH MAY BE CAUSED BY VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY, OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. THE DISCREPANCIES WITH THE REPEAT TESTS MAY BE EXPLAINED BY LOW VIRAL TITERS IN THE SPECIMEN, HOWEVER BD WAS ONLY ABLE TO ANALYZE THE REPEAT RUN OF 10 SAMPLES (RUN 598 SAMPLE B9, RUN 518 SAMPLES A3 AND A9, RUN 529 SAMPLE B3, RUN 540 SAMPLE B6, RUN 557 SAMPLE B4, RUN 558 SAMPLE B6, RUN 564 SAMPLE B8, RUN 565 SAMPLE B9 AND RUN 577 SAMPLE A4) SINCE NO REPEAT TEST COULD BE FOUND IN THE DATABASE PROVIDED FOR THE OTHER SAMPLES IDENTIFIED BY THE CUSTOMER. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. OVERALL, THE REAGENTS ARE NOT SUSPECTED OF BEING IN CAUSE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS WITH THE BD SARS-COV-2 REAGENTS FROM LOTS 0182255, 0233783, 0240506, 0274382, 0274398, 0290223, 0302002, 0302996, 0338462, 0338473, 0353952, 1012622, 1012624, 1039514, 1068080 AND 1074032. THE ROOT CAUSE WAS NOT IDENTIFIED BUT POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY AND/OR CONTAMINATION BY CUSTOMERS ARE SUSPECTED AND AN INSTRUMENT CONTRIBUTION IS ALSO SUSPECTED FOR SOME OF THE REPORTED CUSTOMER ISSUE, THIS INFORMATION WAS TRANSFERRED TO THE BD TECHNICAL SERVICE FOR FURTHER INVESTIGATION (TICKET 01449388). BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA). H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT INFORMATION WAS RECEIVED. THE FOLLOWING CORRECTED LOT NUMBERS WERE REPORTED FOR THIS COMPLAINT: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0182255. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-01-25. H.4. DEVICE MANUFACTURE DATE: 2020-06-30. D.4. MEDICAL DEVICE LOT #: 0233783. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-02-19. H.4. DEVICE MANUFACTURE DATE: 2020-08-20. D.4. MEDICAL DEVICE LOT #: 0240506. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-03-13 H.4. DEVICE MANUFACTURE DATE: 2020-08-27. D.4. MEDICAL DEVICE LOT #: 0274382. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-12. H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0274398. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-17. H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0290223. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-05-28. H.4. DEVICE MANUFACTURE DATE: 2020-10-16. D.4. MEDICAL DEVICE LOT #: 0302996. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-04. H.4. DEVICE MANUFACTURE DATE: 2020-10-28. D.4. MEDICAL DEVICE LOT #: 0302002. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-11. H.4. DEVICE MANUFACTURE DATE: 2020-10-28. D.4. MEDICAL DEVICE LOT #: 0338462. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-18. H.4. DEVICE MANUFACTURE DATE: 2020-12-03. D.4. MEDICAL DEVICE LOT #: 0338473. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-25. H.4. DEVICE MANUFACTURE DATE: 2020-12-03. D.4. MEDICAL DEVICE LOT #: 0353952. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-07-09. H.4. DEVICE MANUFACTURE DATE: 2020-12-18. D.4. MEDICAL DEVICE LOT #: 1012622. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-07-30. H.4. DEVICE MANUFACTURE DATE: 2021-01-12. D.4. MEDICAL DEVICE LOT #: 1012624. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-07-30. H.4. DEVICE MANUFACTURE DATE: 2021-01-12. D.4. MEDICAL DEVICE LOT #: 1039514. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-08-27. H.4. DEVICE MANUFACTURE DATE: 2021-02-08. D.4. MEDICAL DEVICE LOT #: 1068080. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-09-10. H.4. DEVICE MANUFACTURE DATE: 2021-03-09. D.4. MEDICAL DEVICE LOT #: 1074032. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-09-10. H.4. DEVICE MANUFACTURE DATE: 2021-03-15.

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1047329 MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 1026941 MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 69 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE SAME ASSAY ON THE BD MAX AND THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WEAK POSITIVE COULD NOT BE REPEATED REPETITION WITH BD MAX, SAME ASSAY".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 69 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE SAME ASSAY ON THE BD MAX AND THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WEAK POSITIVE COULD NOT BE REPEATED REPETITION WITH BD MAX, SAME ASSAY".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 69 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE SAME ASSAY ON THE BD MAX AND THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WEAK POSITIVE COULD NOT BE REPEATED REPETITION WITH BD MAX, SAME ASSAY"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853874 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1