BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE ROM TEST

    MDR report key: 20110083 · Received August 30, 2024

    Report

    Report Number
    1122376-2024-00002
    Event Type
    Death
    Date Received
    August 30, 2024
    Date of Event
    July 22, 2024
    Report Date
    November 11, 2024
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY USER. THEY DID NOT USE ANY OTHER ASSESSMENTS IN CONJUNCTION WITH THE AMNISURE TEST FOR DIAGNOSIS OF ROM. A SIGNIFICANT AMOUNT OF BLOOD WAS PRESENT IN THE SECOND AMNISURE TEST SAMPLE. WHEN THERE IS A SIGNIFICANT PRESENCE OF BLOOD ON THE SWAB, THE TEST CAN MALFUNCTION AND IS NOT RECOMMEND. OUR INVESTIGATION CONCLUDED THAT THE KIT LOT IS FUNCTIONING AS EXPECTED, AND NO CORRECTIVE ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 0

    THE LOT APPEARS TO BE 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. THE TEST WAS PERFORMED AFTER THE PATIENT HAD REPORTED FLUID LEAKAGE FOR SEVERAL DAYS. THE AMNISURE ROM TEST INSTRUCTIONS FOR USE STATES THE FOLLOWING IN THE LIMITATIONS OF THE TEST SECTION: 1. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION. 2. FAILURE TO DETECT MEMBRANE RUPTURE DOES NOT ASSURE THE ABSENCE OF MEMBRANE RUPTURE. 3. IN RARE CASES, WHEN A SAMPLE IS TAKEN 12 HOURS OR LATER AFTER A RUPTURE HAS OCCURRED AND THE LEAKAGE OF AMNIOTIC FLUID HAS STOPPED, THE TEST MAY NOT DETECT ROM DUE TO SEVERAL FACTORS, INCLUDING (BUT NOT LIMITED TO) RESEALING OF THE RUPTURE, DENATURING ANTIGEN, ETC. PERIODIC RETESTING IN SUCH CASES MAY BE ADVISABLE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A FETAL DEATH TO ANSM AFTER AN UNEXPECTED NEGATIVE AMNISURE RESULT. MOTHER REPORTED LEAKAGE FOR SEVERAL DAYS PRIOR TO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096251 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 57502225

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| D