MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-19 for AMNISURE ROM TEST FMRT-1 FMRT-1-25-US manufactured by Qiagen Sciences, Llc.
[188701073]
On (b)(6) 2019 customer reported unexpected negative amnisure results for 3 patients with no adverse outcomes. Additional information and return product was requested from customer. Follow up information was received 1/28/2020. The malfunction was not confirmed on returned material, however was observed in retained product testing at a rate within the labeled performance characteristics of the product. No other customers have reported issues with this lot. Qiagen's overall evaluation does not indicate a systemic problem with this lot.
Patient Sequence No: 1, Text Type: N, H10
[188701074]
A customer reported patient in labor, grossly ruptured, ferning and pooling positive, nitrazine and amnisure negative. Patient admitted and successfully delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2020-00001 |
| MDR Report Key | 9730231 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2019-12-02 |
| Device Manufacturer Date | 2019-09-09 |
| Date Added to Maude | 2020-02-19 |
| 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, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 6867876 |
| Manufacturer G1 | QIAGEN SCIENCES, LLC |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN, MD |
| Manufacturer Country | US |
| 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 | 2020-02-19 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | 56307021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN SCIENCES, LLC |
| Manufacturer Address | 19300 GERMANTOWN RD GERMANTOWN, MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |