BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10503335 · Received September 8, 2020

    Report

    Report Number
    1119779-2020-00315
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 7, 2020
    Report Date
    October 19, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K20-259 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 CONDUCT BY BD AND BIOGX. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THIS LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER PROVIDED 2 RUNS AND REPORTED A FALSE POSITIVE N2 IN RUN #383, POSITION A1 AND A NEGATIVE RESULT IN RUN #381, POSITION A5. AMPLIFICATION CURVE ANALYSIS REVEALED A LATE BUT TRUE AMPLIFICATION OF THE N2 TARGET IN RUN 383 BUT NO AMPLIFICATION OF THE N2 TARGET IN RUN 381. ANALYSIS OF CURVE IN RUN #383 SHOWS THAT CT OF THE N2 AMPLIFICATION CURVE IS LATE, THE ENDPOINT IS HIGH, WITH A PCR CURVE SHAPE INDICATIVE OF TRUE AMPLIFICATION OF THE TARGET, AT A LOW LOAD, NEAR THE ASSAY LIMIT OF DETECTION (LOD). ANOTHER HYPOTHESIS IS CONTAMINATION DURING SAMPLES PREPARATION. THERE IS NO COMPLAINT TREND RELATED TO FALSE POSITIVE RESULTS WITH THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-259. THE ROOT CAUSE WAS NOT FOUND. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX OR BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN (CAPA). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Additional Manufacturer Narrative · 1

    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 HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970158 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-259

    Patients

    Seq Age Sex Outcome Treatment
    1 Other