BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSOM CARD PREGNANCY TEST

    MDR report key: 531820 · Received March 3, 2004

    Report

    Report Number
    2030538-2004-00003
    Event Type
    Malfunction
    Date Received
    March 3, 2004
    Date of Event
    February 1, 2004
    Report Date
    March 2, 2004
    Manufacturer
    GENZYME DIAGNOSTICS
    Product Code
    JHJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PT TESTED NEGATIVE ON THE OSOM CARD PREGNANCY TEST ON AN UNSPECIFIED DATE. THE TEST WAS PERFORMED ON URINE (SPECIFIC GRAVITY UNKNOWN). ACCORDING TO THE REPORTER, THE TEST "TURNED POSITIVE WELL AFTER THE READ TIME" AND THE SITE HAD USED "A CYTOLOGY BRUSH FOR A PAP SMEAR THAT IS NOT RECOMMENDED FOR A PREGNANT PT." THE PT'S LAST MENSTRUAL PERIOD WAS NOT PROVIDED. THE REPORTER COULD NOT CONFIRM THAT CONFIRMATORY HUMAN CHORIONIC GONADOTROPIN (HCG) OR PREGNANCY TESTING WAS PERFORMED. TO DATE, NO FETAL OR PT INJURY HAS BEEN REPORTED. NO INFORMATION WAS PROVIDED ON THE PT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSOM CARD PREGNANCY TEST NI JHJ GENZYME DIAGNOSTICS 102 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention