MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for AMNISURE ROM manufactured by Qiagen Gmbh.
[100272597]
Patient Sequence No: 1, Text Type: N, H10
[100272598]
An amnisure result was invalid meaning no control line at all was present. From this same box on the following day, there were 2 additional amnisure tests that were invalid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7276625 |
| MDR Report Key | 7276625 |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-02-09 |
| Report Date | 2018-02-14 |
| Date Reported to FDA | 2018-02-14 |
| Date Reported to Mfgr | 2018-02-14 |
| Date Added to Maude | 2018-02-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE ROM |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | NQM |
| Date Received | 2018-02-16 |
| Lot Number | 557016546 |
| ID Number | FMRT 1-25 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN GMBH |
| Manufacturer Address | 19300 GERMANTOWN RD GERMANTOWN MD 20874 US 20874 |
| Brand Name | AMNISURE ROM |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | PPM |
| Date Received | 2018-02-16 |
| Lot Number | 557016546 |
| ID Number | FMRT 1-25 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN GMBH |
| Manufacturer Address | 19300 GERMANTOWN RD GERMANTOWN MD 20874 US 20874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-16 |