BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25HCG

    MDR report key: 1951805 · Received January 6, 2011

    Report

    Report Number
    2518658-2011-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WITHOUT PATIENT SAMPLES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING DISCREPANT (+) SERUM VS. (-) SERUM URINE QUALITATIVE TEST RESULTS 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 ICON 25 HCG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1