BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25HCG

    MDR report key: 1811791 · Received August 23, 2010

    Report

    Report Number
    2518658-2010-00005
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS URINE. RETAIN DEVICES TESTED BY BCI USING CONTROLS AND CONFIRMED NEGATIVE CLINICAL URINE SAMPLE GAVE EXPECTED RESULTS. A CLEAR ROOT CAUSE CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING DISCREPANT (+) SERUM VS. (-) SERUM URINE QUALITATIVE TEST RESULTS ON SIX PATIENTS OBTAINED FROM THE ICON 25 TEST KIT. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1