BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE ROM TEST

    MDR report key: 7317815 · Received March 6, 2018

    Report

    Report Number
    1122376-2018-00002
    Event Type
    Death
    Date Received
    March 6, 2018
    Date of Event
    December 13, 2016
    Report Date
    March 6, 2018
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS NOT REPORTED WITHIN 30 DAYS BECAUSE QIAGEN HAS INFORMATION AVAILABLE THAT WOULD ENABLE A PERSON WHO IS QUALIFIED TO MAKE A MEDICAL JUDGMENT TO REASONABLY CONCLUDE THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. HOWEVER, IN AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF OPEN COMMUNICATION, QIAGEN IS PROVIDING AN MDR REPORT FOR THIS CASE DUE TO THE PROXIMITY OF THE TEST TO A DEATH, DESPITE THE ABSENCE OF REASONABLE CAUSATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017 COMPLAINT #(B)(4) WAS REPORTED OF AN UNEXPECTED NEGATIVE RESULT. PATIENT AT (B)(6) (PRE-VIABLE) TESTED FOR ROM AND RESULT WAS NEGATIVE. PATIENT REMAINED HOSPITALIZED UNDER OBSERVATION AND 24 HOURS LATER A FETAL DEATH OCCURRED JUST PRIOR TO OR VERY SOON AFTER BIRTH. PATIENT WAS DIAGNOSED WITH INFECTION OF THE FETAL MEMBRANES AND HER WBC COUNT WAS ELEVATED. THE NURSE STATED THAT THE AMNISURE TEST RESULT DID NOT CAUSE OR CONTRIBUTE TO THE FETAL DEATH. THE AMNISURE TEST WAS USED AS INTENDED WITH OTHER CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161856 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 551013472

    Patients

    Seq Age Sex Outcome Treatment
    1 Death