BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10431451 · Received August 20, 2020

    Report

    Report Number
    1119779-2020-00286
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 27, 2020
    Report Date
    October 7, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULT WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 445003) LOT 0121412 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE QC RESULTS WERE COMPLIANT. THE CUSTOMER COMPLAINED OF DISCREPANT AND FALSE POSITIVE RESULTS WHEN USING THE BD SARS-COV-2 ASSAY. TWO PICTURES OF 2 RUN FILES, WERE RECEIVED. RUN 287 SHOWS THAT ALL SIX SAMPLES OBTAINED POSITIVE N2 RESULTS. THE N2 CURVES SHOWS TRUE AMPLIFICATION WITH END POINT (EP) VALUES BETWEEN APPROXIMATELY 300 AND 1500. SUCH HIGH EP VALUES DO NOT SUGGEST A COLOR COMPENSATION ISSUE, SINCE IN SUCH CASES THE EP VALUES ARE MUCH LOWER (NEAR THRESHOLD). MOREOVER, NO PCR CURVE GLITCH IS PRESENT. THESE SAMPLES APPEAR TO BE TRUE POSITIVES. THE FACT THAT ALL THE SAMPLES IN THE RUN ARE POSITIVE COULD HOWEVER SUGGEST A CONTAMINATION. NONETHELESS, TRUE POSITIVE RESULTS CANNOT BE EXCLUDED. RUN 288 CONTAINED ONE POSITIVE (LANE B6) AND ONE NEGATIVE (LANE B7) CONTROLS. THE POSITIVE CONTROL IS VERY STRONG WITH A CT VALUE AROUND 10. THE NEGATIVE CONTROL, RIGHT NEXT TO THE POSITIVE CONTROL SHOWS TRUE AMPLIFICATION IN THE N2 CHANNEL, WITH A HIGH EP AROUND 5000. CROSS CONTAMINATION, OR CONTAMINATION FROM THE ENVIRONMENT COULD EXPLAIN THIS POSITIVE RESULT. THE MOST PROBABLE HYPOTHESIS TO EXPLAIN THE FALSE COV-2 POSITIVE RESULTS IS A CONTAMINATION ISSUE. THE CAUSE OF THE CONTAMINATION IS UNCLEAR BUT COULD BE DUE TO CROSS CONTAMINATION BETWEEN THE LABORATORY EQUIPMENT OR DURING PREPARATION OF THE SAMPLES. OVERALL, THE BD SARS-COV-2 REAGENTS IS NOT SUSPECTED TO BE IN CAUSE. THERE IS NO COMPLAINT TREND FOR FALSE POSITIVE RESULTS ON THE BD MAX SARS-COV-2 REAGENTS LOT 0121412. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULT WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME. EUA #: EUA(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM 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 #: 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 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM 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
    899721 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0121412

    Patients

    Seq Age Sex Outcome Treatment
    1 Other