MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-09 for AMNISURE FMRT-1 FMRT-1-25-CA manufactured by Amnisure International, Llc.
[4595458]
Pt presented with minor blood. The following day ultrasound showed no amniotic fluid present and pt was not reporting signs/symptoms. Facility reported the fetus died. Amnisure test was negative. Facility did not indicate further details of when the amnisure test was performed, the gestational age of the pt or details of sample taken for the amnisure test.
Patient Sequence No: 1, Text Type: D, B5
[12084254]
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 unclear whether the test was not performed according to the product instructions for use. The healthcare facility reported unexpected negative results although the pt presented with no amniotic fluid present and minor blood. The amnisure product instructions for use states that a false negative may occur when a sample is taken 12 hours or later after a rupture, due to obstruction of the rupture by the fetus or resealing of the amniotic sac.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2014-00004 |
| MDR Report Key | 3873849 |
| Report Source | 07 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-06-09 |
| Date Mfgr Received | 2013-09-10 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-06-17 |
| 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 ROAD |
| 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 FETAL MEMBRANE RUPTURE TEST |
| Product Code | NQM |
| Date Received | 2014-06-09 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-CA |
| Lot Number | A2019 |
| Device Expiration Date | 2014-08-01 |
| 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 STREET, 6TH FLOOR BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-06-09 |