BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE ROM TEST

    MDR report key: 8609625 · Received May 14, 2019

    Report

    Report Number
    1122376-2019-00002
    Event Type
    Death
    Date Received
    May 14, 2019
    Report Date
    June 12, 2019
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT FOR MDR 1122376-2019-00002. AFTER SEVERAL ATTEMPTS WE ARE NOT ABLE TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER REGARDING THIS EVENT. IT APPEARS THAT THE TEST WAS USED CORRECTLY IN CONJUNCTION WITH OTHER CLINICAL TESTS AND EVALUATIONS AND THAT A DECISION WAS MADE TO RELEASE THE PATIENT AFTER AN OBSERVATION PERIOD BASED ON THE PATIENT'S WHOLE CLINICAL PICTURE AND SUBSEQUENT TO DETERMINING THAT THE AMNIOTIC FLUID LEVELS WERE INCREASING.

    Additional Manufacturer Narrative · 1

    THE KNOWN INFORMATION IS AS FOLLOWS: PATIENT AT (B)(6) GESTATION PRESENTED AT THE HOSPITAL AND WAS TESTED USING AMNISURE. BLOOD WAS PRESENT IN THE SAMPLE. THE AMNISURE RESULT WAS NEGATIVE. AMNIOTIC FLUID LEVELS WERE DETERMINED TO BE INCREASING VIA AFI, AND PATIENT WAS RELEASED FROM THE HOSPITAL AFTER AN UNSPECIFIED OBSERVATION PERIOD. SOMETIME WITHIN A WEEK (UNSPECIFIED), THE PATIENT RETURNED TO THE HOSPITAL AND DELIVERED PREMATURELY, RESULTING IN FETAL DEATH. CHORIOAMNIONITIS WAS PRESENT AT THE TIME OF DELIVERY. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. IT IS LIKELY THAT THE AMNISURE RESULT WAS CORRECT SINCE OTHER CLINICAL TESTING AND ASSESSMENTS ALSO DID NOT INDICATE ROM. THE AMNISURE TEST DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT; HOWEVER, IN AN ABUNDANCE OF CAUTION, AN MDR IS BEING SUBMITTED.

    Description of Event or Problem · 1

    A REPORT OF A POTENTIAL FALSE NEGATIVE AMNISURE RESULT WAS RECEIVED THROUGH A QIAGEN SALES REPRESENTATIVE. A PATIENT AT (B)(6) GESTATION WAS TESTED WITH AMNISURE AND ANOTHER CLINICAL METHOD, BOTH NOT INDICATING ROM. PATIENT WAS ADMITTED FOR OBSERVATION AND SUBSEQUENTLY RELEASED. SHE RETURNED TO THE HOSPITAL AN UNSPECIFIED NUMBER OF DAYS LATER AND DELIVERED PREMATURELY, RESULTING IN FETAL DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400699 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death