BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE

    MDR report key: 15834368 · Received November 18, 2022

    Report

    Report Number
    MW5113380
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 15, 2022
    Report Date
    November 16, 2022
    Manufacturer
    QIAGEN
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT CAME INTO TRIAGE REPORTING QUESTIONABLE RUPTURE OF MEMBRANES. PT DENIED HAVING LEAKING ON CHUX ON ADMISSION. DR (B)(6) CALLED FOR AMNISURE. AMNISURE PERFORMED, NOTED TO HAVE FLUID COMING OUT OF HOLLOW END OF Q-TIP DURING PROCEDURE. THIS RN NITRAZINED FLUID LEAKING FROM AMISURE Q-TIP AND IMMEDIATELY POSITIVE. WHILE AWAITING 10 MIN FOR AMNISURE PT REPORT LARGE AMOUNT OF LEAKING ON CHUX, CHUX CHANGED PER RN AND WERE SATURATED WITH FLUID, NITRAZINE POSITIVE OF FLUID ON CHUX. AFTER 10 MIN NOTED AMNISURE TO BE NEGATIVE. DR (B)(6) DECIDED THEN TO PERFORM FERNING. MD PERFORMED FERN TEST AND REPORTED BACK PT WAS POSITIVE FOR FERNING AND THUS RUPTURE OF MEMBRANES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371392 AMNISURE IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S). NQM QIAGEN 57203698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown