BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10228219 · Received July 3, 2020

    Report

    Report Number
    1119779-2020-00202
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INV-20-PLC-199 WAS COMPLETED ON 2020-07-08. IT CONCERNED THREE DISCREPANT RESULTS OBTAINED WITH BD BIOGX SARS COV-2 REAGENTS FOR BD MAX¿, USED IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0125851. IT CONSISTED IN VERIFICATION OF THE COMPLAINTS HISTORY, AS WELL AS VERIFICATION OF THE MANUFACTURING AND CUSTOMER DATA. THE COMPLAINTS HISTORY SHOWED 16 OTHER COMPLAINTS ON BD BIOGX SARS COV-2 REAGENTS FOR DISCREPANT OR FALSE POSITIVE RESULTS IN THE LAST TWELVE MONTHS, INCLUDING TWO FOR THE LOT K20-116. SINCE THE BD BIOGX SARS COV-2 REAGENTS ARE MANUFACTURED BY BIOGX, BD IS UNABLE TO EVALUATE IF A PRODUCT ISSUE IS IN CAUSE. CUSTOMER DATA ANALYSIS SHOWED THAT THE DISCREPANT RESULTS WERE LINKED TO SAMPLES AT THE LIMIT OF DETECTION OF THE BIOGX ASSAY. SINCE INTERNAL CONTROL AMPLIFICATION WAS COMPARABLE TO THE OTHER SAMPLES IN THE SAME RUNS, THE EXTRACTION PROCESS BY THE BD MAX¿ EXK¿ TNA-3 WAS NOT SUSPECTED OF BEING THE CAUSE OF THE DISCREPANCIES OBTAINED. RETAIN MATERIAL TESTING OF THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0125851 WOULD NOT PROVIDE MORE INFORMATION THAN WHAT IS AVAILABLE FROM THE FINAL QC TEST. MOREOVER, BD MAX¿ EXK¿ TNA-3 IS AN OPEN SYSTEM ASSAY, WITHOUT PRIMERS AND PROBES TO VERIFY POSITIVE TARGETS IN OUR FACILITY. BD MAX¿ EXK¿ TNA-3 KIT LOT 0125851 RETAIN MATERIAL WAS THUS NOT TESTED. UPDATE RISK MANAGEMENT FILE: NO UPDATE PERFORMED BY BD SINCE BD DOES NOT OWN THE PRODUCT RISK MANAGEMENT FILE SINCE THE PRODUCT IS MANUFACTURED BY A PARTNER (BIOGX). THIS PRODUCT IS AVAILABLE ON THE MARKET WITH THE FDA EMERGENCY USE AUTHORIZATION. THE ROOT CAUSE WAS FOUND AS SAMPLE LOADED WITH TARGETED DNA NEAR THE LIMIT OF DETECTION OF THE ASSAY. THERE IS NO COMPLAINT TREND RELATED TO DISCREPANT RESULTS WITH THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-116. BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN (CAPA). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM REPORTED FALSE POSITIVE RESULTS WERE OBTAINED BY LABORATORY PERSONNEL. CONFIRMATION TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD. THE RESULTS WERE NOT REPORTED OUT AND THERE WAS NO INDICATION OF PATIENT IMPACT.

    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

    THE CUSTOMER REPORTED THAT WHILE USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM REPORTED FALSE POSITIVE RESULTS WERE OBTAINED BY LABORATORY PERSONNEL. CONFIRMATION TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD. THE RESULTS WERE NOT REPORTED OUT AND THERE WAS NO INDICATION OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694419 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other