MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for CLINITEK STATUS PLUS manufactured by Siemens Healthcare Diagnostics Inc..
[42300819]
Patient Sequence No: 1, Text Type: N, H10
[42300820]
Completed quality control of clinitek (urine tests) on 03/30/2016, both passed and recorded results in the log book. No record recalled of level 1 and 2 by poc on 03/30/2016. Review of results in machine indicated level 1 but not level 2.
Patient Sequence No: 1, Text Type: D, B5
[42625302]
Patient Sequence No: 1, Text Type: N, H10
[42625303]
Completed quality control of clinitek (urine tests) on (b)(6) 2016, both passed and recorded results in the log book. No record recalled of level 1 and 2 by poc on (b)(6) 2016. Review of results in machine indicated level 1 but not level 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5566975 |
| MDR Report Key | 5566975 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-03-30 |
| Report Date | 2016-04-04 |
| Date Reported to FDA | 2016-04-04 |
| Date Reported to Mfgr | 2016-04-04 |
| Date Added to Maude | 2016-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS PLUS |
| Generic Name | URINE ANALYZER |
| Product Code | LJX |
| Date Received | 2016-04-11 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 3400 MIDDLEBURY ST ELKHART IN 46516 US 46516 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-11 |