BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BDMAX SARS-COV-2 REAGENTS

    MDR report key: 10033024 · Received May 7, 2020

    Report

    Report Number
    1119779-2020-00081
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY INVESTIGATION INV-20-PLC-130 WAS COMPLETED ON 2020-05-21. IT CONCERNED DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS KIT LOT 0093901 AND CONSISTED IN ANALYSIS OF THE COMPLAINTS HISTORY, CUSTOMER DATA, AS WELL AS VERIFICATION OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS KIT LOT 0093901 AND OF THE BD MAX¿ TNA-3 KIT FROM LOT 0084567. MOREOVER, THE RETAIN MATERIAL FROM THESE TWO LOTS WERE TESTED. THE COMPLAINTS HISTORY SHOWED FOUR OTHER COMPLAINTS ON BD SARS-COV-2 KIT LOT 0093901, FOR UNR AND FALSE POSITIVE RESULTS, ALL FROM THE CURRENT CUSTOMER, CAUSED BY CONTROL OR INSTRUMENT CROSSTALK ISSUE. NO OTHER COMPLAINT WAS RECEIVED ON THE BD MAX¿ TNA 3 KIT FROM LOT 0084567 THE COMPLAINT HISTORY WAS ALSO VERIFIED FOR OTHER COMPLAINTS CONCERNING A SIMILAR ISSUE (FALSE POSITIVE OR DISCREPANT RESULT) WITH THE BD SARS-COV-2 AND 3 OTHER COMPLAINTS WERE RECEIVED IN THE LAST TWELVE MONTHS ON THIS ASSAY, INCLUDING THE ONE FROM THE CURRENT CUSTOMER. THOSE COMPLAINTS ARE STILL UNDER INVESTIGATION. AS FOR THE BD MAX¿ EXK¿ TNA-3 KIT, 13 OTHER COMPLAINTS WERE RECEIVED IN THE LAST 12 MONTHS CONCERNING FALSE POSITIVE OR DISCREPANT RESULTS, MOSTLY CAUSED BY LOD, PARTNER AND ALTERNATIVE METHOD). OVERALL, NO REAGENT ISSUE WAS IDENTIFIED. MANUFACTURING AND QC DATA SHOWED THAT BD SARS-COV-2 KIT LOT 0093901 AS WELL AS THE BD MAX¿ TNA-3 KIT FROM LOT 0084567 WERE WITHIN SPECIFICATIONS AND MET THE QC CRITERIA FOR RELEASE AND USE. NO FALSE RESULT WAS OBTAINED. MOREOVER, THEY WERE WITHIN THE TRENDS FOR THE LAST TWELVE MONTHS. THE RETAIN MATERIAL GAVE EXPECTED RESULTS. BOTH BD SARS-COV-2 KIT LOT 0093901 AND BD MAX¿ TNA-3 KIT FROM LOT 0084567 STILL PERFORMED AS EXPECTED. ANALYSIS OF THE CURVES OF THE 3 SAMPLES TAGGED BY THE CUSTOMER SHOWED THAT THE POSITIVE RESULTS OBTAINED WERE NOT THE RESULT OF TRUE AMPLIFICATION. ANALYSIS IN RAW SHOWED GLITCHES AND WAVY CURVES, WHICH MAY HAVE BEEN CAUSED BY PRESENCE OF BUBBLES IN THE PCR CARTRIDGE. A FOLLOW UP WAS DONE WITH THE FSE THAT WAS ON SITE ON MAY 7TH TO REPLACE READER A ON THE CUSTOMER¿S INSTRUMENT AND DURING QUALIFICATION OF THE INSTRUMENT, BUBBLES WERE OBSERVED ON B SIDE. THEREFORE, THE MOST LIKELY CAUSE OF THE CUSTOMER¿S FALSE POSITIVE RESULTS IS PRESENCE OF BUBBLES, CAUSED BY AN INSTRUMENT ISSUE. NONETHELESS, PRESENCE OF 175 L TIPS (ARTICLE 500030941) IN THE BD MAX¿ EXK TNA-3 KIT USED BY THE CUSTOMER CAN ALSO CONTRIBUTE TO THE PRESENCE OF BUBBLES, AS IT IS KNOWN THAT A BUBBLE CAN APPEAR IN THE TIP DURING PIPETTING WHEN THOSE TIPS ARE USED. UPDATE RISK MANAGEMENT FILE: SINCE THE ISSUE IS MOST LIKELY RELATED TO AN INSTRUMENT ISSUE, THE REAGENT RISK ANALYSIS DOESN¿T NEED TO BE UPDATED. AS FOR THE TIP POTENTIALLY CAUSING AN UNR, CAPA 1177233 IS ALREADY ONGOING TO FIND THE ROOT CAUSE OF THE ISSUE. CURRENT ASSESSMENT IS STILL VALID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE RELEASED TO PHYSICIANS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVE PATIENT RESULTS WHEN RUNNING THE BD MAX SARS-COV-2 ASSAY."

    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 THAT WHILE USING KIT BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (B)(6) RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE RELEASED TO PHYSICIANS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVE PATIENT RESULTS WHEN RUNNING THE BD MAX SARS-COV-2 ASSAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495092 KIT BDMAX SARS-COV-2 REAGENTS SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other