MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-28 for AMNISURE FMRT-1 manufactured by Amnisure International, Llc.
[4686014]
A complaint was received on (b)(4) 2013 regarding a pt who was at (b)(6) gestation and had first reported signs/symptoms of rupture 24 hours before being tested, and was not reporting continuous leakage. The pt's amniotic fluid index was 22 and she tested negative with nitrazine and amnisure. Clinical staff noticed a creamy discharge from the pt's vaginal orifice. Pt was sent home at around 10:45am. Pt returned to hospital 8 hours (5:30 pm) later and tested positive with amnisure and the clinical decision was to discharge and send home. Pt returned the next day and displayed symptoms of obvious rom and had developed a fever. Pt was induced and she delivered a stillborn fetus.
Patient Sequence No: 1, Text Type: D, B5
[11819070]
The company has evaluated this event and has determined that the result obtained from the device did not contribute or cause to the death of the fetus. However, the company has decided to submit this mdr for info purposes in an abundance of caution and to ensure full compliance with 21 cfr part 803. The company will supplement this mdr with additional info, as necessary. Based on the info provided, it is clear that the test was not performed according to the product instructions for use. The healthcare facility reported unexpected negative results although the pt first reported signs/symptoms of rupture 24 hours before being tested. The amnisure product instructions for use states that a false negative may occur when a sample is taken 12 hours of later after a rupture due to obstruction of the rupture by the fetus a rupture due to obstruction of the rupture by the fetus or resealing of the amniotic sac. It should be noted that the pt also presented with other complications. In general, the product instruction for use advises physicians to evaluate all results in conjunction with additional clinical info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2014-00003 |
| MDR Report Key | 3844576 |
| Report Source | 07 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-22 |
| Date Mfgr Received | 2013-10-30 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-06-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE |
| Generic Name | RAPID FETAL MEMBRANE RUPTURE TEST |
| Product Code | NQM |
| Date Received | 2014-05-28 |
| Model Number | FMRT-1 |
| Lot Number | A2021A |
| Device Expiration Date | 2014-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMNISURE INTERNATIONAL, LLC |
| Manufacturer Address | 24 SCHOOL ST, 6TH FLOOR BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-05-28 |