BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JANT HCR URINE COMBO PREGNANCY TEST

    MDR report key: 3622311 · Received February 6, 2014

    Report

    Report Number
    MW5034243
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 15, 2014
    Manufacturer
    JANT
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT URINE PREGNANCY TEST # (B)(4). RESULT WAS EQUIVOCAL OR UNDETERMINABLE USING JANT PRODUCT # PF864. LOT # 040948, EXPIRATION DATE 08/2015. RESULT OF QUANTITATIVE HCG WAS 87,731 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77282 JANT HCR URINE COMBO PREGNANCY TEST PREGNANCY TEST LCX JANT 040948

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other