BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE ROM TEST

    MDR report key: 9730227 · Received February 19, 2020

    Report

    Report Number
    1122376-2020-00003
    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 NOT IN LABOR, GROSSLY RUPTURED, FERNING, NITRAZINE AND POOLING POSITIVE, AND AMNISURE NEGATIVE. PATIENT ADMITTED AND SUCCESSFULLY DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194394 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 56307021

    Patients

    Seq Age Sex Outcome Treatment
    1