MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-14 for AMNISURE ROM TEST FMRT-1 FMRT-1-25-US manufactured by Qiagen Sciences, Llc.
[108235955]
This malfunction was found on one test strip that was returned by a customer for an unrelated investigation. It could not be reproduced on any retained test strips. Qiagen's overall evaluation does not indicated a systemic problem with false negatives in this lot. The performance is within the labeled characteristics of the product. Serious injuries are not likely if this malfunction were to recur. However, this report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[108235956]
A false negative result was observed with one test strip during internal testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2018-00004 |
| MDR Report Key | 7512913 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-05-04 |
| Device Manufacturer Date | 2017-05-16 |
| Date Added to Maude | 2018-05-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-05-14 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | 557016546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-14 |