MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-14 for AMNISURE ROM TEST FMRT-1 FMRT-1-25-US manufactured by Qiagen Sciences, Llc.
[145032003]
The known information is as follows: patient at (b)(6) gestation presented at the hospital and was tested using amnisure. Blood was present in the sample. The amnisure result was negative. Amniotic fluid levels were determined to be increasing via afi, and patient was released from the hospital after an unspecified observation period. Sometime within a week (unspecified), the patient returned to the hospital and delivered prematurely, resulting in fetal death. Chorioamnionitis was present at the time of delivery. Further information has been requested from the customer. It is likely that the amnisure result was correct since other clinical testing and assessments also did not indicate rom. The amnisure test did not cause or contribute to the adverse event; however, in an abundance of caution, an mdr is being submitted.
Patient Sequence No: 1, Text Type: N, H10
[145032004]
A report of a potential false negative amnisure result was received through a qiagen sales representative. A patient at (b)(6) gestation was tested with amnisure and another clinical method, both not indicating rom. Patient was admitted for observation and subsequently released. She returned to the hospital an unspecified number of days later and delivered prematurely, resulting in fetal death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2019-00002 |
| MDR Report Key | 8609625 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-14 |
| Date of Report | 2019-06-12 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Manufacturer G1 | QIAGEN SCIENCES, LLC |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE ROM TEST |
| Generic Name | AMNISURE ROM TEST |
| Product Code | NQM |
| Date Received | 2019-05-14 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN SCIENCES, LLC |
| Manufacturer Address | 19300 GERMANTOWN ROAD GERMANTOWN MD 20874 US 20874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-05-14 |