BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT BDMAX SARS-COV-2 REAGENTS

    MDR report key: 10052929 · Received May 13, 2020

    Report

    Report Number
    1119779-2020-00103
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE INVESTIGATION INV-20-PLC-137 WAS COMPLETED ON 2020-05-20 AND CONCERNS FALSE POSITIVE RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM FROM LOT 0093900. IT CONSISTED IN THE ANALYSIS OF THE COMPLAINT HISTORY, MANUFACTURING AND QC DATA, AS WELL AS ANALYSIS OF THE CUSTOMER DATA. COMPLAINTS HISTORY SHOWED ONE OTHER COMPLAINTS ON THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM FROM LOT 0093900 FOR READER SATURATION WARNING AND FOUR OTHER COMPLAINTS CONCERNING FALSE POSITIVE RESULTS WITH A BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM IN THE LAST TWELVE MONTHS AND ALL OF THEM ARE STILL IN INVESTIGATION. MANUFACTURING REVIEW SHOWS THAT 48 SAMPLES WERE TESTED IN NEGATIVE ON THE BD MAX¿ INSTRUMENT AND RESULTS WERE AS EXPECTED, EXCEPT FOR ONE FALSE POSITIVE STATUS RESULTING TO A NONSPECIFIC AMPLIFICATION. MOREOVER, ALTHOUGH THIS IS A NEW PRODUCT, KIT LOT 0093900 QC RESULTS WERE WITHIN THE TRENDS. NO DATA WAS PROVIDED. HOWEVER, THE CUSTOMER REPORTED THAT SOME LABORATORY ASSISTANTS WERE HANDLING SPECIMENS AND PREPARING THE REAGENT STRIPS WITHOUT CHANGING THEIR GLOVES. THE CUSTOMER ALSO IDENTIFIED SEVERAL OTHER POTENTIAL WORKFLOW STEPS THAT COULD HAVE CAUSED CROSS CONTAMINATION, INCLUDING PIPETTING TECHNIQUES DURING THE SBT PREPARATION. SINCE THE WORKFLOW WAS CORRECTED AND THAT RIGOROUS CLEANING WAS ADDED, THE ISSUE WAS RESOLVED. THE MOST PROBABLE CAUSE OF THE FALSE POSITIVE RESULTS IS CROSS CONTAMINATION BY ONE POSITIVE PATIENT DURING SAMPLES PREPARATION. THERE IS NO COMPLAINT TREND FOR FALSE POSITIVE RESULT FOR THE KIT BD MAX SARS-COV-2 REAGENTS ASSAY LOT 0093900. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULT WAS IDENTIFIED BY THE CUSTOMER AS A CONTAMINATION DUE TO USER MANIPULATION. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION PERFORMED SINCE ISSUE IS RELATED TO USER MANIPULATION. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE KIT BDMAX SARS-COV-2 REAGENTS ERRONEOUS RESULTS WERE REPORTED. THE CUSTOMER STATED THEY HAD A NEGATIVE CONTROL TEST AS POSITIVE, AS WELL AS 9 PATIENTS ON THE SAME RUN TEST AS COVID POSITIVE. THE RUN WAS REPEATED DUE TO THE NEGATIVE CONTROL FAILURE. ON THE REPEAT RUN, 8 OF THE PATIENTS THAT PREVIOUSLY TESTED AS POSITIVE RETESTED AS NEGATIVE. 1 PATIENT WAS SENT TO THE HOSPITAL AS A PRECAUTION PRIOR TO THE REPEAT TESTING.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING THE KIT BDMAX SARS-COV-2 REAGENTS ERRONEOUS RESULTS WERE REPORTED. THE CUSTOMER STATED THEY HAD A (B)(6) CONTROL TEST AS (B)(6), AS WELL AS 9 PATIENTS ON THE SAME RUN TEST AS COVID (B)(6). THE RUN WAS REPEATED DUE TO THE NEGATIVE CONTROL FAILURE. ON THE REPEAT RUN, 8 OF THE PATIENTS THAT PREVIOUSLY TESTED AS POSITIVE RETESTED AS NEGATIVE. 1 PATIENT WAS SENT TO THE HOSPITAL AS A PRECAUTION PRIOR TO THE REPEAT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514970 KIT BDMAX SARS-COV-2 REAGENTS SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other