BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG

    MDR report key: 2032167 · Received March 29, 2011

    Report

    Report Number
    2518658-2011-00006
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN DEVICES TESTED BY BCI USING CONTROLS AND CONFIRMED POSITIVE CLINICAL URINE SAMPLE (49MIU/ML) GAVE EXPECTED RESULTS. CUSTOMER DID NOT RETURN THE PATIENT URINE SAMPLE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING DISCREPANT (-) URINE TEST RESULTS OBTAINED FROM THE ICON 25 HCG TEST KIT. PATIENT USED FOUR OVER THE COUNTER (OTC) PREGNANCY TEST AND GOT POSITIVE (+) RESULTS ON ALL FOUR OTC TEST DEVICES. A QUANTITATIVE SERUM TEST GAVE A POSITIVE (+) RESULT AT 40MIU/ML. TEST WAS REPEATED ON SAME URINE SAMPLE ON A SECOND ICON 25 HCG TEST DEVICE AND A NEGATIVE (-) RESULT WAS OBTAINED. PATIENT WENT BACK TO DO FOUR MORE OCT TESTS AND GOT POSITIVE RESULTS (+) ON THE FOUR ADDITIONAL TESTS. NO EFFECT TO PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER INC. NA HCG0100185

    Patients

    Seq Age Sex Outcome Treatment
    1