BEUDAMED
    FDA Adverse Event Other Summary report: N

    HCG COMBO MERIDIAN IMMUNOCARD STAT!

    MDR report key: 2593864 · Received May 25, 2012

    Report

    Report Number
    2030538-2012-00002
    Event Type
    Other
    Date Received
    May 25, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 25, 2012
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    JHI
    PMA / PMN Number
    K043385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINED OF A FALSE NEGATIVE URINE RESULT WHICH WAS CONFIRMED (AFTER IUD PLACEMENT) BY A BETA SERUM QUANTITATIVE RESULT OF 92 MIU/ML. PRODUCT IFU STATES THAT RESULTS SHOULD BE CONFIRMED WITH A QUANTITATIVE TEST PRIOR TO PERFORMANCE OF ANY CRITICAL MEDICAL PROCEDURE. THE IUD WAS REMOVED AND THE PT RELEASED FROM CARE. CUSTOMER REPORTED PT SUBSEQUENTLY MISCARRIED.

    Description of Event or Problem · 1

    INFO WAS RECEIVED FROM CUSTOMER THAT A PT MISCARRIED. PT HAD RECEIVED AN IUD AFTER A FALSE NEGATIVE HCG QUALITATIVE TEST. QUANTITATIVE TEST (PERFORMED AFTER IUD HAD BEEN INSERTED) INDICATED THE PT WAS PREGNANT. IUD WAS REMOVED AT THAT TIME AND PT WAS RELEASED FROM CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCG COMBO MERIDIAN IMMUNOCARD STAT! JHI (HCG TEST) JHI SEKISUI DIAGNOSTICS, LLC 755425 08111279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other