BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE

    MDR report key: 3844576 · Received May 28, 2014

    Report

    Report Number
    3005345832-2014-00003
    Event Type
    Death
    Date Received
    May 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AMNISURE INTERNATIONAL, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS EVALUATED THIS EVENT AND HAS DETERMINED THAT THE RESULT OBTAINED FROM THE DEVICE DID NOT CONTRIBUTE OR CAUSE TO THE DEATH OF THE FETUS. HOWEVER, THE COMPANY HAS DECIDED TO SUBMIT THIS MDR FOR INFO PURPOSES IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFO, AS NECESSARY. BASED ON THE INFO PROVIDED, IT IS CLEAR THAT THE TEST WAS NOT PERFORMED ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE. THE HEALTHCARE FACILITY REPORTED UNEXPECTED NEGATIVE RESULTS ALTHOUGH THE PT FIRST REPORTED SIGNS/SYMPTOMS OF RUPTURE 24 HOURS BEFORE BEING TESTED. THE AMNISURE PRODUCT INSTRUCTIONS FOR USE STATES THAT A FALSE NEGATIVE MAY OCCUR WHEN A SAMPLE IS TAKEN 12 HOURS OF LATER AFTER A RUPTURE DUE TO OBSTRUCTION OF THE RUPTURE BY THE FETUS A RUPTURE DUE TO OBSTRUCTION OF THE RUPTURE BY THE FETUS OR RESEALING OF THE AMNIOTIC SAC. IT SHOULD BE NOTED THAT THE PT ALSO PRESENTED WITH OTHER COMPLICATIONS. IN GENERAL, THE PRODUCT INSTRUCTION FOR USE ADVISES PHYSICIANS TO EVALUATE ALL RESULTS IN CONJUNCTION WITH ADDITIONAL CLINICAL INFO.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON (B)(4) 2013 REGARDING A PT WHO WAS AT (B)(6) GESTATION AND HAD FIRST REPORTED SIGNS/SYMPTOMS OF RUPTURE 24 HOURS BEFORE BEING TESTED, AND WAS NOT REPORTING CONTINUOUS LEAKAGE. THE PT'S AMNIOTIC FLUID INDEX WAS 22 AND SHE TESTED NEGATIVE WITH NITRAZINE AND AMNISURE. CLINICAL STAFF NOTICED A CREAMY DISCHARGE FROM THE PT'S VAGINAL ORIFICE. PT WAS SENT HOME AT AROUND 10:45AM. PT RETURNED TO HOSPITAL 8 HOURS (5:30 PM) LATER AND TESTED POSITIVE WITH AMNISURE AND THE CLINICAL DECISION WAS TO DISCHARGE AND SEND HOME. PT RETURNED THE NEXT DAY AND DISPLAYED SYMPTOMS OF OBVIOUS ROM AND HAD DEVELOPED A FEVER. PT WAS INDUCED AND SHE DELIVERED A STILLBORN FETUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314796 AMNISURE RAPID FETAL MEMBRANE RUPTURE TEST NQM AMNISURE INTERNATIONAL, LLC FMRT-1 A2021A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death