BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY/CSF PROTEIN

    MDR report key: 1636886 · Received March 22, 2010

    Report

    Report Number
    2050012-2010-00125
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 22, 2010
    Manufacturer
    BECKMAN COULTER BIOMEDICAL IRELAND LIMITED
    Product Code
    JGQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION AND QC WERE RECOVERING WITH SPECIFICATIONS. THE SPECIMEN TYPE WAS URINE. PATIENT SAMPLES WERE REQUESTED FROM THE CUSTOMER AND TESTED IN HOUSE ON THE AU 640 INSTRUMENT AND ON A DIFFERENT ANALYZER. THE AU 640 ANALYZER GENERATED NEGATIVE RESULTS (EXCEPT FOR ONE SAMPLE), AND THE DIFFERENT INSTRUMENT GAVE "OIR LO" RESULTS FOR ALL SAMPLES. ALTHOUGH REACTION MONITOR DATA IS CONSISTENT WITH AN INTERFERENCE, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING NEGATIVE RESULTS FOR URINE PROTEIN PATIENT SAMPLES GENERATED ON AU CHEMISTRY SYSTEM USING URINARY/CSF PROTEIN REAGENT. THE RESULTS WERE REPORTED OUT OF THE LAB. UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINARY/CSF PROTEIN URINARY/CFS PROTEIN JGQ BECKMAN COULTER BIOMEDICAL IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1