BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEAVA HCG URINE TEST

    MDR report key: 425744 · Received October 30, 2002

    Report

    Report Number
    MW1026613
    Event Type
    Malfunction
    Date Received
    October 30, 2002
    Date of Event
    October 18, 2002
    Report Date
    October 22, 2002
    Manufacturer
    THERMO BIOSTAR INC.
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAINT PINK AND BLUE INDICATOR LINES NOTED AFTER APPROPRIATE URINE DIPPING AND 5 MIN ON TIMER UNTIL READ TIME. IF TEST IS POSITIVE: FAINT PINK AND BLUE LINES. IF TEST IS NEGATIVE: FAINT PINK LINES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCEAVA HCG URINE TEST URINE PREGNANCY TEST DIAGNOSTIC LCX THERMO BIOSTAR INC. * 017718 (& OTHERS)

    Patients

    Seq Age Sex Outcome Treatment
    1 *