MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for SIEMENS AMM manufactured by Siemens.
[38386630]
We get an "abnl assay" next to qc or patient results. When the report prints out, you get a flag "abnl assay". This flag means you cannot report the test for qc or patients. In order to fix this problem, we take the reagent flex off the analyzer and put it back on, and we rerun the qc or patient (because it flats randomly on the qc or patient result).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060148 |
| MDR Report Key | 5434029 |
| Date Received | 2016-02-09 |
| Date of Report | 2016-02-09 |
| Date of Event | 2016-02-09 |
| Date Added to Maude | 2016-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SIEMENS AMM |
| Generic Name | AMMONIA RGT REF #DF119 |
| Product Code | JIF |
| Date Received | 2016-02-09 |
| Lot Number | BC6258 |
| Device Expiration Date | 2016-09-14 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-09 |