BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE ROM TEST

    MDR report key: 5930614 · Received September 6, 2016

    Report

    Report Number
    1122376-2016-00013
    Event Type
    Death
    Date Received
    September 6, 2016
    Date of Event
    August 7, 2016
    Report Date
    September 6, 2016
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT; IT COULD NOT BE DETERMINED WHEN OR IF ROM OCCURED. HOSPITAL STAFF COULD NOT PROVIDE CLEAR DETAILS ON THEIR EXECUTION OF THE TEST PROCEDURE. ADDITIONALLY, THE CUSTOMER REPORTED THAT NO OTHER CLINICAL ASSESSMENTS WERE PERFORMED IN CONJUNCTION WITH THE AMNISURE AS INDICATED IN THE PACKAGE INSERT. RETAINED SAMPLES TESTED PASSED ALL SPECIFICATIONS. THE INVESTIGATION COULD NOT CONFIRM THE DEVICE CAUSED OR CONTRIBUTED TO AN UNEXPECTED NEGATIVE RESULT OR THAT THE RESULT WAS INCORRECT. THE CAUSE FOR THE FETAL DEATH IS UNKNOWN. THE IMPACT OF A FALSE NEGATIVE RESULT IS THAT IT MAY LEAD TO THE AVOIDANCE OF NECESSARY GESTATIONAL-AGE SPECIFIC OBSTETRICAL MEASURES, INCLUDING HOSPITALIZATION OF THE MOTHER, ADMINISTRATION OF ANTIBIOTICS AND CORTICOSTEROIDS, AND INDUCTION OF LABOR. THIS RISK IS MITIGATED BY THE INTENDED USE OF THE AMNISURE ROM TEST IN THAT IT SHOULD NOT BE USED AS THE SOLE BASIS FOR CLINICAL ASSESSMENT AND TREATMENT OF PATIENTS. A NEGATIVE RESULT DOES NOT PRECLUDE RUPTURE BECAUSE TEST RESULTS DEPEND ON THE PROPER SPECIMEN COLLECTION TECHNIQUE AND CONDITIONS AS WELL AS THE AVAILABILITY OF SUFFICIENT PROTEIN TO PROVIDE A CONCENTRATION WITHIN THE ASSAY'S LIMIT OF DETECTION. THE LIMITATIONS OF THE TEST STATE THAT RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION AND THAT FAILURE TO DETECT MEMBRANE RUPTURE DOES NOT ASSURE THE ABSENCE OF MEMBRANE RUPTURE. NO RETURNS PROVIDED.

    Description of Event or Problem · 1

    ON AUGUST 11, 2016, (B)(4) WAS REPORTED OF AN ALLEGED FALSE NEGATIVE RESULT AND SUBSEQUENTLY THERE WAS A FETAL DEATH. THE PATIENT WAS AT 41 WEEKS AND 3 DAYS GESTATION. ON WEDNESDAY, (B)(6) 2016, THE PATIENT PRESENTED AT THE (B)(6) WITH A COMPLAINT OF "LEAKING". SHE WAS SENT TO A NEARBY HOSPITAL ((B)(6) HOSPITAL) FOR AN AMNISURE TEST. THE TEST RESULTS WERE NEGATIVE. THE NURSE THAT COLLECTED THE SAMPLE STATED THAT THE PATIENT HAD A YELLOW/GREENISH DISCHARGE THAT APPEARED TO BE A VAGINAL DISCHARGE VS. RUPTURE OF MEMBRANES. THERE IS NO INFORMATION AVAILABLE REGARDING THE IDENTIFICATION (INFECTION, MECONIUM, ETC) OF THE VAGINAL DISCHARGE THAT WAS PRESENT AT THE TIME OF TESTING. THE PATIENT CAME BACK TO THE CLINIC THE NEXT DAY, THURSDAY, (B)(6) 2016, AND THERE WAS NO MENTION OF LEAKING FLUID. ON SUNDAY, (B)(6), THE FETUS HAD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581991 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 55407537

    Patients

    Seq Age Sex Outcome Treatment
    1 Death