BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 20 HCG

    MDR report key: 1234068 · Received November 4, 2008

    Report

    Report Number
    2916283-2008-00010
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHI
    PMA / PMN Number
    K020439
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED. RETAIN DEVICES PERFORMED AS EXPECTED WHEN TESTED BY BECKMAN COULTER INC. (BCI) USING CONTROLS AND LOW (53MIU) AND HIGH (106MIU) QUANTITATIVE POSITIVE CLINICAL URINE SAMPLE. PT SAMPLES WERE NOT SUBMITTED TO BCI. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING DISCREPANT NEGATIVE (-) URINE TEST RESULTS FROM THE ICON 20 HCG TEST KIT. THE CUSTOMER REPORTED THAT AT LEAST SIX (6) PTS GAVE NEGATIVE (-) URINE RESULTS WHEN TESTED WITH THE ICON 20 HCG TEST KIT. UPON ULTRASOUND TESTING, POSITIVE (+) RESULTS WERE OBTAINED. PER ULTRASOUND RESULT, THE PTS VARIED FROM 7-13 WEEKS GESTATION. NO INJURY HAS BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 20 HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER, INC. NA HCG468D11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA