BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRITECH ICON II HCG

    MDR report key: 135083 · Received November 24, 1997

    Report

    Report Number
    2022635-1997-00005
    Event Type
    Injury
    Date Received
    November 24, 1997
    Date of Event
    October 25, 1997
    Report Date
    November 14, 1997
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT PRESENTED AT THE USER FACILITY AFTER TESTING POSITIVE WITH AN OTC URINE HOME PREGNANCY TEST ON 10/17/97. PT WAS RETESTED AT THE USER FACILITY ON 10/17/97 USING THE ICON II HCG TEST. THE ICON II HCG TEST ON THE PTS SERUM WAS NEGATIVE. ON 10/25/97 THIS PT WAS TREATED FOR A RUPTURED FALLOPIAN TUBE DUE TO AN ECTOPIC PREGNANCY. THE DISCREPANCY IN THE RESULTS WOULD NORMALLY INDICATE A REPEAT TEST. THE LABELING STATES THAT WHEN PREGNANCY IS SUSPECTED, A NEGATIVE TEST SHOULD BE REPEATED ON A SAMPLE COLLECTED AT LEAST 48 HRS LATER. NO RETEST WAS PERFORMED PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRITECH ICON II HCG HCG IMMUNOCONCENTRATION TEST KIT JHJ BECKMAN INSTRUMENTS, INC. ICON II HCG 790334

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O