BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10553703 · Received September 18, 2020

    Report

    Report Number
    1119779-2020-00337
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 27, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K20-306 WAS PERFORMED. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-306 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER PROVIDED 2 RUNS AND REPORTED A POSITIVE N2 IN RUN #902, LANE B4 AND A NEGATIVE RESULT IN RUN #904, LANE B12. ANALYSIS OF THE CURVE FROM THE FIRST SAMPLE, RUN #902, LANE B4 SHOW A TRUE AMPLIFICATION WITH A LATE CT BUT A HIGH ENDPOINT IN THE INITIAL TEST. THE REPEAT TESTING, (RUN#904, LANE B4) SHOWS A FLUORESCENCE SIGNAL INCREASE AROUND THE SAME CT BUT NOT SUFFICIENT TO CALL A POSITIVE. THE N2 POSITIVE RESULT IS CONSISTENT WITH A TRUE LOW POSITIVE SAMPLE AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY AND NOT DETECTED DURING THE SECOND RUN. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS COMPLAINTS ON THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-306. THE ROOT CAUSE FOR THE DISCREPANTS RESULTS WAS NOT IDENTIFIED. BD AND BIOGX CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021892 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other