BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE ROM TEST

    MDR report key: 7317818 · Received March 6, 2018

    Report

    Report Number
    1122376-2018-00001
    Event Type
    Death
    Date Received
    March 6, 2018
    Date of Event
    August 14, 2017
    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
    IN, 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 REPORTS 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. AMNISURE ROM TEST WAS PERFORMED GREATER THAN 12 HOURS AFTER SUSPECTED RUPTURE AND THERE MAY NOT HAVE BEEN AMNIOTIC FLUID PRESENT AT TIME OF TESTING. PATIENT ((B)(6)) WAS TESTED 16 HOURS AFTER SUSPECTED RUPTURE. CUSTOMER REPORTED AN ODOR WAS NOTED THAT SUGGESTED INFECTION. THE PATIENT WAS TOLD THAT THE BABY WAS IN DANGER AND IT WAS RECOMMENDED TO INDUCE LABOR. THE PATIENT WAS NON-COMPLAINT ACCORDING TO NURSING STAFF REFUSING TREATMENT. THE NEXT DAY THE PATIENT RETURNED AND THE BABY HAD DIED AND THE MOTHER HAD INFECTION. THE AMNISURE TEST WAS USED AS INTENDED WITH OTHER CLINICAL INFORMATION AND DID NOT DIRECTLY OR INDIRECTLY CAUSE OR CONTRIBUTE TO THE ADVERSE OUTCOME AS THE PATIENT DECLINED RECOMMENDED MEDICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161858 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 557010334

    Patients

    Seq Age Sex Outcome Treatment
    1 Death