BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL

    MDR report key: 439837 · Received January 23, 2003

    Report

    Report Number
    MW1027343
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    January 7, 2003
    Report Date
    January 15, 2003
    Manufacturer
    QUIDEL CORP.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREGNANCY TEST GAVE A FALSE NEGATIVE READING. (I.E. TEST INDICATED PT WAS NOT PREGNANT WHEN THEY WERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIDEL QUICKVUE ONE-STEP HCG URINE TEST JHJ QUIDEL CORP. * 70007

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other