BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIANTNBS WITH GDM 3.1 SOFTWARE

    MDR report key: 3458984 · Received October 15, 2013

    Report

    Report Number
    2915274-2013-00010
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    September 13, 2013
    Report Date
    October 15, 2013
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    GKA
    PMA / PMN Number
    K080911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR PRELIMINARY INVESTIGATION BIO-RAD OBTAINED: BACK UP FROM THE INVESTIGATION'S DATABASE, PUNCH FILE, SUMMARY AND CHORMATOGRAMS OF INITIAL RUN AND REPEAT RUN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CUSTOMER LOCATED IN (B)(6) WAS USING THE VARIANT NBS SICKLE CELL PROGRAM AND NOTICED THAT A SAMPLE ((B)(6)) APPEARED TWICE ON THE SUMMARY REPORT. WITHIN THE SAME RUN, A SAMPLE RESULT ((B)(6)) SHOWED A FLAT LINE WITH NO PEAKS ON THE CHROMATOGRAM. ON (B)(6) 2013, THE OPERATOR REPEATED THE ENTIRE RUN TO FURTHER INVESTIGATE THE RESULTS THAT APPEARED TWICE ON THE SUMMARY REPORT AS WELL AS THE FLAT LINE CHROMATOGRAM. THE SUMMARY REPORT FROM THE SECOND RUN CONTAINED NO REPEATED SAMPLES AND ALL CHROMATOGRAMS SHOWED PEAKS (NO FLAT LINES). THE INCIDENT WAS REPORTED TO BIO-RAD LABS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529356 VARIANTNBS WITH GDM 3.1 SOFTWARE ABNORMAL HEMOGLOBIN QUANTITATION GKA BIO-RAD LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1