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 FMRT-1-25-US manufactured by Amnisure International Llc.
[4686009]
An unexpected amnisure negative result was received for patient on (b)(6) 2013, at 2am. The sample was collected at the bedside by a nurse and sent to the lab for testing. The test was performed by a lab technician. The sample contained meconium. It was also stated that the patient first reported signs/symptoms of rupture greater than 12 hours and up to 3 days prior to admission and testing. An afi was also run with a result of 9. The patient went into labor and delivery which resulted in fetal death.
Patient Sequence No: 1, Text Type: D, B5
[11804321]
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, the company has decided to submit this mdr for informational purposes in an abundance of caution and to ensure full compliance with 21 cfr part 803. The company will supplement this mdr with additional information, 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 an unexpected negative result although meconium as present in the patient sample. The performance of the amnisure test has not been established in the presence of meconium as stated in the product information for use. Additionally, the patient complained of symptoms of rom that began greater than 12 hours and up to 3 days before the test was performed. 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 obstructions of the rupture by the fetus or resealing of the amniotic sac. In general, the product instruction for use advises physicians to evaluate all results in conjunction with additional clinical information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2014-00002 |
| MDR Report Key | 3844614 |
| Report Source | 07 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-22 |
| Date Mfgr Received | 2013-07-22 |
| 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 | 3 |
| 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 | 9300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Single Use | 0 |
| 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 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | A2021 |
| ID Number | NA |
| 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 STREEET 6TH FLOOR BOSTON MD 02109 US 02109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-05-28 |