BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG

    MDR report key: 2168555 · Received July 19, 2011

    Report

    Report Number
    2518658-2011-00013
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED BY BEC USING RETAINER TEST DEVICES FROM THE COMPLAINT LOT (0110033) AND RETURN DEVICES INDICATE DEVICES PERFORMED AS EXPECTED. EXPECTED POSITIVE (+) RESULTS WERE OBTAINED FOR LOT USING POSITIVE CONTROL AND CONFIRMED CLINICAL URINE (164500MIU/ML). THE PATIENT'S TURBID URINE SAMPLE PRODUCED A MODERATE POSITIVE RESPONSE AND THE PATIENT'S URINE SAMPLE AFTER HYDRATION PRODUCED A STRONG POSITIVE RESPONSE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT THAT PATIENT'S URINE SAMPLE WAS TESTED WITH THE ICON 25 HCG TEST KIT AND A NEGATIVE (-) RESULT WAS OBTAINED. THE SAMPLE WAS RE-TESTED FOUR TIMES AND ALL RESULTS WERE NEGATIVE (-). A SERUM SAMPLE COLLECTED FROM THE PATIENT GAVE A RESULT OF 176,000MIU/ML. PATIENT'S URINE WAS OBSERVED TO BE TURBID. THE PATIENT WAS GIVEN HYDRATION VIA IV, AND PATIENT'S URINE FOLLOWING THE HYDRATION WAS OBSERVED TO BE CLEARER GIVING A WEAK POSITIVE (+) RESULT. THE TEST WAS REPEATED FOR FOUR TIMES AND ALL RE-TESTS WERE WEAK POSITIVE (+). ALL TESTS WERE PERFORMED ON THE SAME DAY. NO EFFECT TO PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM JHI BECKMAN COULTER INC. NA HCG0110033

    Patients

    Seq Age Sex Outcome Treatment
    1