BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-BORRELIA (LYME) EIA

    MDR report key: 1412003 · Received June 24, 2009

    Report

    Report Number
    1412003
    Event Type
    Malfunction
    Date Received
    June 24, 2009
    Date of Event
    June 12, 2009
    Report Date
    June 24, 2009
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JIX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    WHILE ANALYZING THE DATA FROM A RECENT RUN OF SPECIMENS, THE TECHNICIAN NOTICED THAT THE POSITIVE CONTROL WAS NOT AS HIGH AS EXPECTED, BUT STILL WITHIN ACCEPTABLE RANGE. DURING THE INVESTIGATION OF THIS, BIORAD WAS CONTACTED. IT WAS DISCOVERED THE A "SCALING FACTOR" SHOULD HAVE BEEN ENTERED INTO THE INSTRUMENT FOR THIS TEST WITH EACH RUN. THE SCALING FACTOR IS SUPPOSED TO BE PRINTED ON THE VIAL WHEN REQUIRED FOR A PROCEDURE. THE VIAL DID NOT CONTAIN THE FACTOR LABEL. NINE PATIENTS HAD LAB RESULTS REPORTED TO THEM THAT WERE INCORRECT. THE PATIENTS WILL HAVE TO COME IN FOR A SECOND TEST.SCALING FACTOR NOT PRINTED ON CALIBRATOR SO TECHNICIAN DID NOT KNOW TO ENTER IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-BORRELIA (LYME) EIA CALIBRATOR JIX BIO-RAD LABORATORIES, INC. * 082132

    Patients

    Seq Age Sex Outcome Treatment
    1 *