BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BDMAX SARS-COV-2 REAGENTS

    MDR report key: 10181784 · Received June 22, 2020

    Report

    Report Number
    1119779-2020-00161
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 26, 2020
    Report Date
    September 4, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0100384. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-10. H.4. DEVICE MANUFACTURE DATE:2020-04-09. H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULT WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# (B)(4) LOT 0100384 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. INITIAL COMPLAINT WAS LOGGED AGAINST LOT NUMBER 0120606 HOWEVER UPON CUSTOMER DATA ANALYSIS, BD SARS-COV-2 REAGENTS KIT LOT 0100384 WAS FOUND TO BE THE TRUE LOT USED TO TEST THE SUSPECTED FALSE POSITIVE SAMPLES. THUS, ONLY THIS KIT LOT WAS INVESTIGATED. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE QC RESULTS WERE COMPLIANT. THE CUSTOMER COMPLAINED OF HIGH RATES OF N1 POSITIVE RESULTS THAT DISPLAYED LOW FLUORESCENCE SIGNAL AND LATE CT VALUES (>30). ONE RUN FILE FROM INSTRUMENT CT0985 WAS PROVIDED FOR THE INVESTIGATION (RUN 484). NO SAMPLE WAS IDENTIFIED IN THE COMPLAINT TEXT, HOWEVER, ONLY TWO SAMPLES PRESENTED A N1 POSITIVE/ N2 NEGATIVE RESULT (POSITION A8 AND B6). THE AMPLIFICATION CURVES OF THOSE SAMPLES WERE ANALYZED. THE RNASEP CONTROL PRESENTS GOOD AMPLIFICATION CURVES, COMPARABLE TO THE OTHER SAMPLES. THE N1 POSITIVE RESULTS OF SAMPLES IN A8 AND B6 LOOK LIKE REAL BUT LATE AND LOW AMPLIFICATIONS. SAMPLES AT THE LIMIT OF DETECTION (LOD) IS THE MOST LIKELY HYPOTHESES TO EXPLAIN THE CUSTOMER RESULTS. INDEED, BASED ON THE PROVIDED DATA, THERE IS NO REASON TO DOUBT THE POSITIVE RESULTS OBTAINED. NONETHELESS, A CONTAMINATION ISSUE COULD ALSO EXPLAIN THESE LATE N1 POSITIVES. MOREOVER, KNOWING THAT ONE POSITIVE CONTROL WAS INCLUDED IN RUN FILE 484 (POSITION A1), IT IS POSSIBLE THAT THOSE TWO SAMPLES WERE CONTAMINATED DURING THE PREPARATION OF THE POSITIVE CONTROL. THE REAGENTS ARE NOT SUSPECTED TO BE THE CAUSE OF THE CUSTOMER ISSUE. THERE IS NO COMPLAINT TREND FOR FALSE POSITIVE RESULTS FOR THE BD MAX SARS-COV-2 REAGENTS LOT 0100384. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULT WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. THERE IS NO ELEMENT INDICATING A PRODUCT ISSUE. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THE FALSE RESULTS WERE NOT REPORTED TO THE CLINICIANS.

    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 A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THE FALSE RESULTS WERE NOT REPORTED TO THE CLINICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641399 KIT BDMAX SARS-COV-2 REAGENTS SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0100384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other