BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ EXK¿ DNA-3

    MDR report key: 12822087 · Received November 16, 2021

    Report

    Report Number
    3007420875-2021-00062
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 23, 2021
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    JJH
    UDI-DI
    00382904428211
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : THE COMPLAINT INVESTIGATION FOR POSITIVE RESULTS (DISCREPANT RESULT) WHEN USING BD MAX EXK DNA-3 KIT (REF # (B)(4) FROM LOT 1103395 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX EXK DNA-3 KIT INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. ASIDE FROM THE INFORMATION AVAILABLE IN THE COMPLAINT TEXT, AT THE TIME THE INVESTIGATION WAS CONDUCTED, DESPITE SEVERAL REQUESTS MADE TO RECEIVE INFORMATION, NO DATA WAS AVAILABLE FROM THE CUSTOMER. BASED ON THE INVESTIGATION AND AVAILABLE INFORMATION, BD WAS UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX EXK DNA-3 USA KIT LOT 1103395. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ EXK¿ DNA-3 FALSE POSITIVE RESULTS WERE OBTAINED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSISTENT POSITIVE RESULTS WITH EACH TEST ON THIS LOT#.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ EXK¿ DNA-3 FALSE POSITIVE RESULTS WERE OBTAINED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSISTENT POSITIVE RESULTS WITH EACH TEST ON THIS LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718669 BD MAX¿ EXK¿ DNA-3 CLINICAL SAMPLE CONCENTRATOR JJH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 442821 1103395 00382904428211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown