MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-30 for AMNISURE FMRT-1 FMRT-1-10-ML-RT manufactured by Amnisure International, Llc.
[16880627]
Adverse event reported by distributor in (b)(6) on (b)(6) 2015. Approximately two months prior to reporting this adverse event, a patient arrived at her ob/gyn complaining of discharge. The patient was at a gestational age of (b)(6) weeks and was carrying twins. An amnisure test was performed and the result was negative. The patient was sent home. The patient returned to the hospital 5 days later complaining of continued discharge. Another amnisure test was performed and the result was again negative. A sonogram was performed and showed a very low afi. A cesarean section was then performed and both fetus' were deceased. The physician was not claiming that there was a false negative result with this incident. The physician stated that there was uncertainty as to whether the patient was ruptured and the low afi may have been due to other clinical conditions.
Patient Sequence No: 1, Text Type: D, B5
[17191960]
The company is unable to obtain information 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 information, as necessary. Our preliminary investigation has identified the following: a) 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. B) the attending physician was unable to confirm that the patient had been leaking amniotic fluid. Due to the patient's condition there may have been other clinical factors that attributed to her low amniotic fluid level, thus amnisure would have provided correct results. C) 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2015-00002 |
| MDR Report Key | 4651981 |
| Report Source | 07 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-24 |
| Date Mfgr Received | 2015-03-09 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-04-02 |
| 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 MEMBRANES RUPTURE TEST |
| Product Code | NQM |
| Date Received | 2015-03-30 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-10-ML-RT |
| Lot Number | A354525, A355744 |
| ID Number | NA |
| Device Expiration Date | 2016-11-01 |
| 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 | 2015-03-30 |