BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE ROM TEST

    MDR report key: 9747867 · Received February 24, 2020

    Report

    Report Number
    1122376-2020-00005
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Report Date
    February 24, 2020
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020 CUSTOMER REPORTED UNEXPECTED NEGATIVE AMNISURE RESULTS WITH NO ADVERSE OUTCOME. DATE OF EVENT IS UNKNOWN CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS. IN AN ABUNDANCE OF CAUTION QIAGEN IS REPORTING THIS INCIDENT AS A POSSIBLE MALFUNCTION. THE LOT IS PERFORMING WITHIN SPECIFICATIONS. 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 AND GROSSLY RUPTURED AND AMNISURE (B)(6). NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211775 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 56309689

    Patients

    Seq Age Sex Outcome Treatment
    1