BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10518736 · Received September 10, 2020

    Report

    Report Number
    1119779-2020-00318
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 22, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA# (B)(4). H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULT WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# (B)(4)) LOT 0133363 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 LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. CUSTOMER PROVIDED 2 RUNS FOR ANALYSIS AND REPORTED A POSITIVE RESULT IN RUN #1575 AND A NEGATIVE RESULT WHEN RETESTED (RUN #1595). ANALYSIS OF THE CURVES SHOW NO FLUORESCENCE ANOMALY FOR THOSE SAMPLES. RESULTS FROM RUN #1575 INDICATED THAT ANOTHER SAMPLE GAVE STRONG AMPLIFICATION IN BOTH N1 AND N2 TARGETS. SINCE THE STRONG POSITIVE SAMPLE WAS LOCATED CLOSE TO THE SAMPLES IDENTIFIED AS DISCREPANT RESULTS, IT IS POSSIBLE THAT A CROSS-CONTAMINATION OCCURRED WHEN HANDLING THE SAMPLES OR THAT THE SAMPLES WERE TRUE POSITIVE RESULTS AT THE ASSAY LIMIT OF DETECTION (LOD) AND, THEREFORE, SUSCEPTIBLE TO GIVE NEGATIVE RESULTS UPON REPEAT. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR FALSE POSITIVE RESULTS FOR THE BD SARS-COV-2 LOT 0133363. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE POSITIVE SAMPLE WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE REPORTED OUT, BUT THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULTS. EUA# (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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 A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE POSITIVE SAMPLE WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE REPORTED OUT, BUT THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULTS. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983701 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0133363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other