BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10525605 · Received September 11, 2020

    Report

    Report Number
    1119779-2020-00322
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 20, 2020
    Report Date
    October 26, 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

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K20-306 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 FALSE POSITIVE N2 IN RUN #874, LANE B8 AND A NEGATIVE RESULT IN RUN #881, LANE A1. ANALYSIS OF THE CURVES FROM FIRST SAMPLE RUN #874, LANE B8 SHOW AN IRREGULAR CURVE WITH A SIGNAL INCREASE AT THE SAME CT VALUE IN BOTH CHANNELS. HOWEVER, THE SIGNAL INCREASE IN THE N2 PCR CURVE CAUSED AN INTERRUPTION OF BACKGROUND CORRECTION GENERATING A STEADY INCREASE OF FLUORESCENCE RESULTING IN A FALSE POSITIVE RESULT. THERE ARE VARIOUS POTENTIAL CONTRIBUTORS THAT COULD LEAD TO THIS TYPE OF CURVE ALL OF WHICH ATTRIBUTED TO A SAMPLE PROCESSING ERROR OF UNKNOWN ORIGIN. ONE OF THE POTENTIAL CONTRIBUTORS COULD BE BUBBLES IN THE CARTRIDGE WELL COMING FROM VARIOUS ELEMENTS (TIPS, INSTRUMENT, WORKFLOW, ETC.). ANALYSIS OF THE CURVES FOR THE SECOND SAMPLE, RUN #881, LANE A1 SHOW NO AMPLIFICATION FURTHER SUPPORTING THE PROBABLE NEGATIVE STATUS OF THE SAMPLE. BASED ON COMPLAINTS REVIEW FOR THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-306, THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR FALSE POSITIVE COMPLAINTS FOR THIS LOT. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    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 ERRONEOUS RESULT WAS ON AN EMPLOYEE THAT IS TESTED WEEKLY. ALL PREVIOUS TEST RESULTS WERE NEGATIVE. A NEW SWAB WAS COLLECTED, THE TEST WAS REPEATED, AND UPON REPEAT THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (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 A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE ERRONEOUS RESULT WAS ON AN EMPLOYEE THAT IS TESTED WEEKLY. ALL PREVIOUS TEST RESULTS WERE NEGATIVE. A NEW SWAB WAS COLLECTED, THE TEST WAS REPEATED, AND UPON REPEAT THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990091 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other