MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-06 for AMNISURE ROM TEST FMRT-1 FMRT-1-25-US manufactured by Qiagen Sciences, Llc.
[101653023]
This event was not reported within 30 days because qiagen has information available that would enable a person who is qualified to make a medical judgment to reasonably conclude that the device did not cause or contribute to the adverse event. However, in an abundance of caution and in the interest of open communication, qiagen is providing an mdr reports for this case due to the proximity of the test to a death, despite the absence of reasonable causation.
Patient Sequence No: 1, Text Type: N, H10
[101653024]
On (b)(6) 2017, complaint #(b)(4) was reported of an unexpected negative result. Amnisure rom test was performed greater than 12 hours after suspected rupture and there may not have been amniotic fluid present at time of testing. Patient ((b)(6)) was tested 16 hours after suspected rupture. Customer reported an odor was noted that suggested infection. The patient was told that the baby was in danger and it was recommended to induce labor. The patient was non-complaint according to nursing staff refusing treatment. The next day the patient returned and the baby had died and the mother had infection. The amnisure test was used as intended with other clinical information and did not directly or indirectly cause or contribute to the adverse outcome as the patient declined recommended medical care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2018-00001 |
| MDR Report Key | 7317818 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-08-14 |
| Date Mfgr Received | 2017-09-25 |
| Device Manufacturer Date | 2017-05-16 |
| Date Added to Maude | 2018-03-06 |
| 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 | 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 | 2018-03-06 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | 557010334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-03-06 |