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 EMRT-1-25-US manufactured by Amnisure International, Llc.
[17952793]
A complaint was received (b)(6) 2015 regarding a pt who was at 22 weeks gestation, presented with bleeding, infection, cramping, low amniotic fluid and rom. Four (4) amnisure (as) tests were administered as well as one (1) fern. The first three (3) as tests and the one (1) fern test were all negative. The fourth (4th) as test was positive after pooling of amniotic fluid taken from pt with decreased amounts of flood in the sample. Pt delivered resulting in a fetal death.
Patient Sequence No: 1, Text Type: D, B5
[18228768]
The company has evaluated this event and has determined that the result obtained from the device did not contribute or cause the death of the fetus. However, informational purposes in an abundance of caution and to ensure full compliance with 21cfr part 803. The company will supplement this mdr with additional info, as necessary. Based on the information 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 there was excessive blood present in the three pt samples. The pt also presented with other complications. The test did perform as expected when a 4th sample tested with significantly less blood present than the first three and an accumulation of amniotic fluid. In general, the product instruction for use advised physicians to evaluate all results in conjunction with additional clinical info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2014-00001 |
| MDR Report Key | 3844613 |
| Report Source | 07 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-22 |
| Date Mfgr Received | 2012-03-15 |
| Device Manufacturer Date | 2011-06-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN RD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE |
| Generic Name | RAPID RETAL MEMBRANCE RUPTURE TEST |
| Product Code | NQM |
| Date Received | 2014-05-28 |
| Model Number | FMRT-1 |
| Catalog Number | EMRT-1-25-US |
| Lot Number | A1010 |
| Device Expiration Date | 2013-06-01 |
| 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 FL BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-05-28 |