BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE ROM TEST

    MDR report key: 9730230 · Received February 19, 2020

    Report

    Report Number
    1122376-2020-00002
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    November 29, 2019
    Report Date
    February 19, 2020
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019 CUSTOMER REPORTED UNEXPECTED NEGATIVE AMNISURE RESULTS FOR 3 PATIENTS WITH NO ADVERSE OUTCOMES. ADDITIONAL INFORMATION AND RETURN PRODUCT WAS REQUESTED FROM CUSTOMER. FOLLOW UP INFORMATION WAS RECEIVED 1/28/2020. THE MALFUNCTION WAS NOT CONFIRMED ON RETURNED MATERIAL, HOWEVER WAS OBSERVED IN RETAINED PRODUCT TESTING AT A RATE WITHIN THE LABELED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. NO OTHER CUSTOMERS HAVE REPORTED ISSUES WITH THIS LOT. QIAGEN'S OVERALL EVALUATION DOES NOT INDICATE A SYSTEMIC PROBLEM WITH THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED PATIENT IN LABOR, GROSSLY RUPTURED, FERNING AND POOLING POSITIVE, AND AMNISURE NEGATIVE. PATIENT ADMITTED AND SUCCESSFULLY DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194395 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 56307021

    Patients

    Seq Age Sex Outcome Treatment
    1