BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10778574 · Received November 3, 2020

    Report

    Report Number
    1119779-2020-00883
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 14, 2020
    Report Date
    January 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS (FALSE POSITIVE) WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 0182253 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED A POSITIVE RESULT N1 TARGET AND THE SAMPLE OBTAINED NEGATIVE RESULTS WITH ANOTHER TESTING METHOD (CEPHEID). CUSTOMER PROVIDED ONE RUN FROM INSTRUMENT CT1614 FOR INVESTIGATION (RUN #230, LANE A01). MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THIS SAMPLE. 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. FLUORESCENCE PATTERN SHOWS ANOMALY WITH HIGH INITIAL FLUORESCENCE VALUES. SUCH FLUORESCENCE ANOMALY AT THE BEGINNING OF THE RUN OFTEN IMPACTS BACKGROUND CORRECTION AND OTHER ALGORITHM ANALYSES WHICH COULD INFLUENCE FINAL RESULTS. BD WAS UNABLE TO IDENTIFY THE CAUSE OF THIS ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 LOT 0182253. 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 A FALSE POSITIVE RESULTS WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT IF ANY REPEAT TESTING WAS PERFORMED AND WHICH TYPE OF CONFIRMATORY METHOD TESTING USED. THE RESULT WAS NOT REPORTED AND THERE WAS NO PATIENT IMPACT. EUA#: (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULTS WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT IF ANY REPEAT TESTING WAS PERFORMED AND WHICH TYPE OF CONFIRMATORY METHOD TESTING USED. THE RESULT WAS NOT REPORTED AND THERE WAS NO PATIENT IMPACT. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244176 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 0182253

    Patients

    Seq Age Sex Outcome Treatment
    1