BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM

    MDR report key: 13419520 · Received February 1, 2022

    Report

    Report Number
    1119779-2022-00179
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 18, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX SARS-COV-2/FLU (REF. (B)(4)) LOT 1266913 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX SARS-COV-2/FLU INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED HIGH RATE OF WEAK COV-2 POSITIVE RESULTS WHEN USING BD MAX SARS-COV-2/FLU KIT LOT 1266913 WHILE NEGATIVE RESULTS WERE OBTAINED WHEN RETESTED WITH THE VIASURE SARS COV2 TEST (FROM CERTEST). CUSTOMER PROVIDED SIX RUN FILES FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE SEVEN DISCREPANT SAMPLES FOUND IN THE RUNS. 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. ANALYSIS OF PCR CURVES SHOWS A LATE AND LOW, BUT TRUE, COV2 AMPLIFICATION WHICH INDICATE THE PRESENCE OF A LOW AMOUNT OF TARGET DNA. LOW POSITIVE SAMPLES CAN OCCUR DUE TO 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. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX SARS-COV-2/FLU LOT 1266913. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR AN ENVIRONMENTAL CONTAMINATION CAN EXPLAIN THE CUSTOMER ISSUE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. RETESTING IS PERFORMED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULTS WITH THE BD MAX SARS COV2 FLU ASSAY (445011).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. RETESTING IS PERFORMED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #(B)(4). THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULTS WITH THE BD MAX SARS COV2 FLU ASSAY (445011).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420810 BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown