BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM

    MDR report key: 15161323 · Received August 3, 2022

    Report

    Report Number
    1119779-2022-01060
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    January 16, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CANCELLING MDR FOR THIS CASE PER THIS REPORT (1119779-2022-01060) IS A LESS-DETAILED DUPLICATE OF ORIGINAL (1119779-2022-00179).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM THE CUSTOMER OBSERVED A FALSE POSITIVITY IN COVID PCR ON N GENE AMPLIFICATION, RESULTING IN MISDIAGNOSIS AND MISDIRECTION OF PATIENTS. THIS EVENT OCCURRED 1 TIME. ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVITY IN COVID PCR ON N GENE AMPLIFICATION, RESULTING IN MISDIAGNOSIS AND MISDIRECTION OF PATIENTS." (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM THE CUSTOMER OBSERVED A FALSE POSITIVITY IN COVID PCR ON N GENE AMPLIFICATION, RESULTING IN MISDIAGNOSIS AND MISDIRECTION OF PATIENTS. . THIS EVENT OCCURRED 1 TIME. ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVITY IN COVID PCR ON N GENE AMPLIFICATION, RESULTING IN MISDIAGNOSIS AND MISDIRECTION OF PATIENTS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033566 BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1266913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown