BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10793398 · Received November 5, 2020

    Report

    Report Number
    1119779-2020-00914
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 19, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-431 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX SINCE LOT K20-431 WAS TESTED ALONG WITH BD MAX EXK TNA-3 LOT 0231396. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-431 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 0231396 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED DISCREPANT RESULTS ON THREE DIFFERENT PATIENT SAMPLES AND PROVIDED THREE RUNS FILES FROM INSTRUMENT CT1703 FOR INVESTIGATION (RUN #430, #432 & #437). THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 PACKAGE INSERT INSTRUCTION FOR USE. THE CUSTOMER REPORTED THREE DISCREPANT RESULTS WITH THE BD BIOGX SARS COV-2 REAGENTS BUT IDENTIFIED ONLY TWO OF THEM IN THE COMPLAINT TEXT. THE PATIENT #1 OBTAINED A POSITIVE N1 RESULT ON THE INITIAL TEST (RUN #432/B5) AND NEGATIVE RESULT ON REPEAT TEST (RUN 437 A12) AND PATIENT #2 OBTAINED A NEGATIVE RESULT ON INITIAL TEST (RUN #430/B8) AND POSITIVE N2 RESULT ON THE REPEAT TEST (RUN #437/B11). MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THOSE SAMPLES. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. ANALYSIS OF THE PCR CURVE SHOWS A TRUE AMPLIFICATION WITHOUT ANOMALY INDICATIVE OF TRUE POSITIVE RESULTS. THESE SAMPLES LOOK LIKE TRUE POSITIVE SAMPLES AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY. HOWEVER, BD IS UNABLE TO CONFIRM THIS HYPOTHESIS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT K20-431. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD & BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. THE SAMPLES WERE RECOLLECTED AND REPEATED ON THE BD MAX. UPON REPEAT THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. (B)(6)

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. THE SAMPLES WERE RECOLLECTED AND REPEATED ON THE BD MAX. UPON REPEAT THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258552 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-431

    Patients

    Seq Age Sex Outcome Treatment
    1