BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEAVA HCG URINE TEST

    MDR report key: 473760 · Received July 17, 2003

    Report

    Report Number
    MW1029061
    Event Type
    Malfunction
    Date Received
    July 17, 2003
    Date of Event
    June 27, 2003
    Report Date
    July 15, 2003
    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

    TWO BOXES OF PREGNANCY TEST KITS WITH NO RED CONTROL LINE VISIBLE ON SEVERAL STRIPS AND SEVERAL STRIPS READING VERY FAINT RED CONTROL LINE. REPORTER SPOKE WITH DR AND LAB. THE LAB WOULD LIKE THE RETURN OF THE TWO TEST KITS FOR FURTHER ANALYSIS - THEY WILL REPLENISH THEIR SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCEAVA HCG URINE TEST HCG URINE TEST LCX THERMO BIOSTAR, INC. * 017766

    Patients

    Seq Age Sex Outcome Treatment
    1 *