FDA.reportPublic FDA data

MAUDE MDR 5930614

MDR report key
5930614
Report number
1122376-2016-00013
Event key
0
Event type
3
Date of event
2016-08-07
Date received
2016-09-06
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. DONNA SOWERS
Address
19300 GERMANTOWN ROAD GERMANTOWN 20874 US
Phone
240-240-2406
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMNISURE ROM TESTAMNISURE ROM TESTQIAGEN SCIENCES, LLCNQMFMRT-1FMRT-1-25-US55407537R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-0601. D

Event Narratives#

N

Patient 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.

D

Patient 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.