BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDS + - OS

    MDR report key: 13117 · Received May 6, 1994

    Report

    Report Number
    MW1001873
    Event Type
    Malfunction
    Date Received
    May 6, 1994
    Report Date
    May 5, 1994
    Manufacturer
    PACIFIC BIOTECH, INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE RPTR WAS SENT THIS PRODUCT BY THE MFR TO REPLACE A TEST THAT HE HAD BEEN USING THAT HAD BEEN DISCONTINUED. IN THE FIRST 3 DAYS OF USE, THERE WERE SEVERAL FALSE NEGATIVE AND FALSE POSITIVE RESULTS WHICH WERE CONFIRMED BY ALTERNATIVE TESTING. THE RESULTS WERE NOT MARGINAL; ONE PT'S SERUM HCG LEVELS WERE 2000-3000 AND THE URINE PREGNANCY TEST READ NEGATIVE. EVENT DATE SHOWN AS WEEK OF 4/25/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDS + - OS URINE PREGNANCY TEST JHJ PACIFIC BIOTECH, INC. 750064.1

    Patients

    Seq Age Sex Outcome Treatment
    1 *