MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-16 for AMNISURE ROM TEST FMRT-1 FMRT-1-25-US manufactured by Qiagen Sciences, Llc.
[102720583]
A maude report was communicated to qiagen that stated 3 test strips did not show a control line resulting in invalid tests. Customer returns were requested and tested along with company retain samples on (b)(6) 2018. The reported problem was confirmed with the customer's returned product where 5 out of 16 test strips tested had no visible control line. The reported problem was not confirmed with retained product where 25 out of 25 test strips tested all had visible control lines. All available inventory containing these test strips has been placed on hold until further investigation can be completed.
Patient Sequence No: 1, Text Type: N, H10
[102720584]
On (b)(6), qiagen received from fda, medwatch report #(b)(4), which was submitted by (b)(6) hospital of (b)(6). The customer reported three invalid tests (no control line present) occured on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2018-00003 |
| MDR Report Key | 7346899 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-16 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2017-05-16 |
| Date Added to Maude | 2018-03-16 |
| 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 | 2018-03-16 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | 557016546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-03-16 |