BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG

    MDR report key: 1170272 · Received September 11, 2008

    Report

    Report Number
    2916283-2008-00008
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 30, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    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 QUANTITATIVE POSITIVE CLINICAL URINE SAMPLE. THE URINE SAMPLE WAS NOT FIRST MORNING VOID AND PATIENT WAS BLEEDING. PRODUCT OR PATIENT SAMPLE WAS NOT SUBMITTED TO BCI FOR VERIFICATION. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. 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 A DISCREPANT NEGATIVE (-) URINE TEST RESULT FROM THE ICON 25 HCG TEST KIT. A PATIENT URINE SAMPLE GAVE A NEGATIVE (-) RESULT WHEN TESTED WITH THE ICON 25 HCG TEST KIT. A QUANTITATIVE TEST WAS PERFORMED USING A SERUM SAMPLE AND A RESULT OF 150 WAS OBTAINED (METHODOLOGY AND UNITS NOT SUPPLIED). IN ADDITION, PATIENT PERFORMED A HOME PREGNANCY TEST 3 DAYS PRIOR AND OBTAINED A POSITIVE (+) RESULT. NO INJURY HAS BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER, INC. NA HCG7109002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA