BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIANT NBS SICKLE CELL PROGRAM

    MDR report key: 3724762 · Received December 16, 2013

    Report

    Report Number
    2915274-2013-00015
    Event Type
    Malfunction
    Date Received
    December 16, 2013
    Date of Event
    November 19, 2013
    Report Date
    December 16, 2013
    Manufacturer
    BIO-RAD LABORATORIES INC.
    Product Code
    GKA
    PMA / PMN Number
    K080911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STUDIES WILL BE PERFORMED AT BIO-RAD TO MEASURE ACTUAL IMPACT OF AN ELUTED DROPPED DISC INTO AN UNSAMPLED WELL.

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER REPORTED A POTENTIAL RISK THAT AN ELUTED SAMPLE DISC THAT CAN ADHERE TO THE SAMPLE PROBE WHICH HAS BEEN SEEN DROPPED ONTO THE MICROPLATE AREA MAY DROP INTO AN UNSAMPLED WELL WHICH MAY CAUSE SAMPLE CONTAMINATION OF THE UNSAMPLED WELL AND POTENTIALLY AN INCORRECT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656924 VARIANT NBS SICKLE CELL PROGRAM ABNOMRAL HEMOGLOBIN QUANTITATION GKA BIO-RAD LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1