MAUDE Adverse Event Report: AMNISURE INTERNATIONAL, LLC AMNISURE; RAPID FETAL MEMBRANES RUPTURE TEST

Model Number FMRT-1

Device Problem False Negative Result (1225)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 02/17/2015

Event Type  Death  

Event Description

Adverse event reported by distributor in (b)(6) on (b)(6) 2015.A patient at (b)(6) weeks gestation went to hosp complaining of signs and symptoms of rom that began 3 hours prior to her arrival at the hosp.An amnisure test was performed and the result was negative.The patient was sent home.The patient returned to a different hosp 10 days later complaining of continued discharge.Another amnisure test was performed and the result was again negative.A sonogram was then performed and showed a extremely low afi.The pregnancy was terminated and the twins had deceased.

Manufacturer Narrative

The company is unable to obtain info to further investigate this event due to a holiday in (b)(6).The company is submitting this mdr in compliance with 21 cfr part 803.The company will supplement this mdr with additional info, as necessary.Our preliminary investigation has identified the following: the intended use of the amnisure rom test, as written in the package insert, indicates that the test is an aid in the detection of rupture of fetal membranes (rom) in pregnant women.As a diagnostic aid, there is an expectation that patient care is based on a multitude of factors/tests/analyses.In this case, an initial ultrasound would have been useful as an additional tool in determining rom status and clinical actions.; the company performed testing on retain samples for the lots implicated and all results passed specifications.Additionally, batch records were reviewed and all testing passed specifications with no deviations noted.

• Brand Name: AMNISURE
• Type of Device: RAPID FETAL MEMBRANES RUPTURE TEST
• Manufacturer (Section D): AMNISURE INTERNATIONAL, LLC; 24 school st, 6th fl; boston MA 02108
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2406867876
• MDR Report Key: 4651984
• MDR Text Key: 5599259
• Report Number: 3005345832-2015-00003
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K081767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-10-ML-RT
• Device Lot Number: A354525, A355744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death