BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10367449 · Received August 5, 2020

    Report

    Report Number
    1119779-2020-00258
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 9, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS OBTAINED WITH BIOGX SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT #K20-150 CONSISTED ONLY IN REVIEW OF THE BATCH HISTORY RECORD BY BIOGX AND IN VERIFICATION OF THE COMPLAINT'S HISTORY BY BD SINCE NO DATA WAS PROVIDED. BIOGX REVIEW OF THE BATCH HISTORY RECORDS INDICATED THAT K20-150 LOT SHOWS NO OBSERVED DEVIATIONS IN PERFORMANCE. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE CUSTOMER RECEIVED DISCREPANT RESULTS FOR 8 DISTINCT SAMPLES WHICH WERE NEGATIVE UPON REPEAT. SINCE NO DATA WAS PROVIDED, IN DEPTH ANALYSIS COULD NOT BE PERFORMED. BD REVIEW OF COMPLAINT HISTORY SHOWS NO SIMILAR COMPLAINT ON LOT K20-150. THE ROOT CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM 8 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. ALL POSITIVE SAMPLES ARE REQUIRED TO BE REPEATED, AND UPON REPEAT THE RESULTS WERE NEGATIVE. PATIENTS WERE ALL REPORTED AS POSITIVE, ACCORDING TO THE FIRST RUN RESULTS. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION. IT IS UNKNOWN IF RESULTS WERE AMENDED AND IF THERE WAS ANY IMPACT TO PATIENTS. (B)(4).

    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 8 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. ALL POSITIVE SAMPLES ARE REQUIRED TO BE REPEATED, AND UPON REPEAT THE RESULTS WERE NEGATIVE. PATIENTS WERE ALL REPORTED AS POSITIVE, ACCORDING TO THE FIRST RUN RESULTS. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION. IT IS UNKNOWN IF RESULTS WERE AMENDED AND IF THERE WAS ANY IMPACT TO PATIENTS. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830999 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other