BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10752092 · Received October 28, 2020

    Report

    Report Number
    1119779-2020-00811
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 13, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS (FALSE POSITIVE) WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 0233788 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 THIS LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED DISCREPANT RESULTS FOR 3 SAMPLES ON TWO RUNS (RUN 8742, A6 AND RUN 8793, A3 & A4) THAT TESTED POSITIVE BUT GAVE NEGATIVE RESULTS WHEN RETESTED. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD MAX SARS-COV-2 REAGENTS PACKAGE INSERT INSTRUCTION FOR USE. CUSTOMER PROVIDED THE TWO RUNS FOR INVESTIGATION FROM INSTRUMENT CT 0282 IN ORDER TO CONDUCT ANALYSIS USING THE PCR CURVE PROFILES. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE THREE DISCREPANT RESULTS. 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. CURVES CONSIST OF NORMAL PCR AMPLIFICATION CURVES SUGGESTING TRUE AMPLIFICATION FOR N1 TARGET WITHOUT ANOMALY, SUGGESTING TRUE POSITIVES RESULTS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR FALSE POSITIVE RESULTS FOR THE BD SARS-COV-2 LOT 0233788 . THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-A FALSE POSITIVE RESULTS WAS OBTAINED. THE SAMPLE WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). . DATE OF EVENT: UNKNOWN. 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 THAT WHILE TESTING FOR SARS-COV-A FALSE POSITIVE RESULTS WAS OBTAINED. THE SAMPLE 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
    1215363 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1