BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON II HCG (URINE)

    MDR report key: 42930 · Received September 30, 1996

    Report

    Report Number
    2022635-1996-00001
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Date of Event
    September 3, 1996
    Report Date
    September 30, 1996
    Manufacturer
    HYBRITECH, INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WHO HAD A POSITIVE HOME PREGNANCY TEST PRESENTED TO HER DR ON 9/3/96. A URINE SAMPLE WAS COLLECTED AND TESTED TWICE ON THE IMMUNOCONCENTRATION ASSAY LOT NUMBER 591597. THE RESULTS OF BOTH TESTS WERE NEGATIVE. CO DETERMINED THAT THE KIT HAD EXPIRED ON 8/13/96. THE EXPIRATION DATE WAS CLEARLY NOTED ON THE PRODUCT. A SERUM SAMPLE COLLECTED THE SAME DAY WAS TESTED USING AN UNKNOWN QUANTITATIVE METHOD WITH AN HCG RESULT OF 11,700 MLU/ML INDICATING THAT THE PT WAS PREGNANT. THE RESULTS OF THE QUANTITATIVE TESTING WAS AVAILABLE ON 9/4/96. NO PROCEDURES WERE PERFORMED ON THE PT DURING THE DISCREPANCY PERIOD. FURTHER TESTING OF THE KIT WAS NOT PERFORMED AT CO AS THE KIT HAD EXPIRED. NO SAMPLE WAS RETURNED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON II HCG (URINE) HCG TEST JHJ HYBRITECH, INC. NA 591597

    Patients

    Seq Age Sex Outcome Treatment
    1 *