BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11531982 · Received March 19, 2021

    Report

    Report Number
    3007420875-2021-00007
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    June 3, 2021
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: B.5. EVENT DESCRIPTION: IT WAS REPORTED WHILE TESTING FOR SARS COV-2 40 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). D.4. LOT NUMBER: SEE H.10. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0274389; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30; H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0274403; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-25; H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0274406; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-23; H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0274408; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30; H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0274419; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-05-21; H.4. DEVICE MANUFACTURE DATE: 2020-09-30. D.4. MEDICAL DEVICE LOT #: 0290219; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-05-14; H.4. DEVICE MANUFACTURE DATE: 2020-10-16. D.4. MEDICAL DEVICE LOT #: 0290221; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-05-28; H.4. DEVICE MANUFACTURE DATE: 2020-10-16. 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 #: 0290224; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-05-21; H.4. DEVICE MANUFACTURE DATE: 2020-10-16. 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 #: 0302978; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-11; H.4. DEVICE MANUFACTURE DATE: 2020-10-28. D.4. MEDICAL DEVICE LOT #: 0302994; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-04; H.4. DEVICE MANUFACTURE DATE: 2020-10-28.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER COMPLAINED ABOUT MORE THAN 40 FALSE POSITIVE RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM FROM 2021-01-01 TO 2021-02-15. NO KIT LOT WAS SPECIFIED SINCE ALL THE LOT NUMBERS USED WERE INVOLVED. THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) FROM ALL LOTS (TWELVE) PRODUCED DURING THAT PERIOD WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE TWELVE LOTS ARE: 0274389, 0274403, 0274406, 0274408, 0274419, 0290219, 0290221, 0290223, 0290224, 0302002, 0302978 AND 0302994. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED A POWER POINT PRESENTATION SHOWING THE CURVES OBTAINED FOR 10 SAMPLES AND THE DATABASE FROM INSTRUMENT CT1832 FOR INVESTIGATION. THE POWER POINT PRESENTATION SHOWS A LATE AMPLIFICATION FOR ONLY N1 OR N2 TARGET FOR ALL OF TEN SAMPLES. ACCORDING TO THE COMPLAINT TEXT AND THE EXAMPLES RECEIVED, CUSTOMER IS QUESTIONING THE POSITIVE RESULTS GIVEN WHEN ONLY ONE OF THE TWO TARGETS IS AMPLIFYING. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND PARAMETERS CORRECTLY CORRESPOND TO THOSE DESCRIBED IN BD SARS-COV-2 REAGENTS PACKAGE INSERT (PI P0255) WITH THE LATEST UPDATE. ANALYSIS OF THE DATABASE ALLOWED TO FIND 3132 SAMPLES TESTED DURING THE PERIOD DESCRIBED BY THE CUSTOMER (FROM 2021-01-01 UNTILL 2021-02-15) AND 7.7% OF THEM OBTAINED A POSITIVE RESULT; 4.9% OBTAINED A POSITIVE RESULT WITH DETECTION OF BOTH N1 AND N2, 2.2% OBTAINED A POSITIVE RESULT WITH DETECTION OF N1 ONLY AND 0.6% OBTAINED A POSITIVE RESULT WITH DETECTION OF N2 ONLY. ANALYSIS OF THE ENTIRE DATABASE (JUNE 2020 TO APRIL 2021) SHOWS THAT, EXCEPT FOR A PEAK OF POSITIVE RESULTS IN NOVEMBER 2020 WHICH COULD BE CAUSED BY AN INCREASE (WAVE) IN NUMBER OF CASES IN THE POPULATION, FLUCTUATIONS IN THE RATE OF POSITIVE RESULTS WERE OBSERVED, BUT WITH NO INCREASE. THIS IS ALSO TRUE FOR SAMPLES WITH ONLY N1 OR N2 POSITIVE RESULTS. CUSTOMER DID NOT MENTION A PARTICULAR LOT FOR THE ISSUE. TWELVE KIT LOTS WERE USED DURING THIS TIME FRAME AND NONE OF THEM SHOWED AHIGHER RATE OF POSITIVE RESULTS. SAMPLES TESTED BETWEEN 2021-01-01 AND 2021-02-15, FOR WHICH ONLY ONE TARGET (N1 OR N2) WAS DETECTED, WERE ASSESSED AND MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED. ALL THE CURVES ANALYZED SHOW A LATE AMPLIFICATION WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE RESULTS. AS MENTIONED IN THE PACKAGE INSERT, SAMPLES WITH AMPLIFICATION OF ONE TARGET ONLY CAN BE CONSIDERED AS POSITIVE. SUCH RESULTS CAN OCCUR WHEN A SAMPLE IS AT THE ASSAY LIMIT OF DETECTION (LOD). IT WAS NOTED THAT STRONG POSITIVE SAMPLES ARE PRESENT IN SOME RUNS PROVIDED, AND CONTAMINATION DURING SAMPLE PREPARATION AND/OR MATERIAL HANDLING COULD ALSO HAVE CONTRIBUTED TO SOME OF THE POSITIVE RESULTS. NEVERTHELESS, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOTS 0274389, 0274403, 0274406, 0274408, 0274419, 0290219, 0290221, 0290223, 0290224, 0302002, 0302978 AND 0302994. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 40 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 40 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426614 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1