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.
[101651951]
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 report 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
[101651952]
On (b)(6) 2017 complaint #(b)(4) was reported of an unexpected negative result. Patient at (b)(6) (pre-viable) tested for rom and result was negative. Patient remained hospitalized under observation and 24 hours later a fetal death occurred just prior to or very soon after birth. Patient was diagnosed with infection of the fetal membranes and her wbc count was elevated. The nurse stated that the amnisure test result did not cause or contribute to the fetal death. The amnisure test was used as intended with other clinical information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2018-00002 |
| MDR Report Key | 7317815 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2017-01-06 |
| 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 | 551013472 |
| Device Expiration Date | 2018-06-01 |
| 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 |