BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE ROM TEST

    MDR report key: 8559917 · Received April 29, 2019

    Report

    Report Number
    1122376-2019-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Report Date
    April 24, 2019
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT PATIENT HAD BEEN USING INTERFERING SUBSTANCES PRIOR TO SAMPLE COLLECTION. CUSTOMER WAS INFORMED THAT TOPICAL MEDICATIONS CAN INTERFERE WITH TEST PERFORMANCE AS STATED IN THE PRODUCT PACKAGE INSERT. NO DEATH, SERIOUS INJURY/ILLNESS OR DETERIORATION OF HEALTH OCCURED. BASED ON ALL CLINICAL INFORMATION AVAILABLE, PATIENT WAS ADMITTED AND SUCCESSFULLY DELIVERED. INITIAL INTERNAL TESTING CONFIRMED ONE FALSE NEGATIVE RESULT AND FURTHER INVESTIGATION IS PENDING. CUSTOMER RESULTS MAY HAVE BEEN AFFECTED BY USE OF TOPICAL MEDICATIONS. IN AN ABUNDANCE OF CAUTION THIS INCIDENT IS BEING REPORTED. THE AMNISURE TEST IS FOR USE BY HEALTHCARE PROFESSIONALS TO AID IN THE DIAGNOSIS OF ROM IN PREGNANT WOMEN REPORTING SIGNS, SYMPTOMS OR COMPLAINTS SUGGESTIVE OF ROM. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION AND NEGATIVE RESULTS ALONE MAY NOT RULE OUT A MEMBRANE RUPTURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE RESULT FOR ONE PATIENT THAT HAD USED HYDROCORTIZONE AND BENZOCAINE AT AN UNKNOWN TIMEFRAME PRIOR TO TESTING. PATIENT WAS IN ACTIVE LABOR AND SUCCESSFULLY DELIVERED 9 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354689 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 557017538

    Patients

    Seq Age Sex Outcome Treatment
    1