MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-11-30 for COBAS 6000 C501 04745914001 manufactured by Roche Diagnostics.
[20617703]
Twelve pts samples with discrepant crp results, only 11 examples were provided: (1) initial results 17. 00 mg/dl, repeat 0. 39 mg/dl; (2) initial result 17. 00 mg/dl, repeat 0. 44 ,g/dl; (3) initial result 17. 00 md/dl, repeat 0. 65 mg/dl; (4) initial result 17. 00 mg/dl, repeat 0. 05 mg/dl; (5) initial result 17. 00 mg/dl , repeat 1. 83 mg/dl; (6) initial result 17. 00 mg/dl, repeat 0. 24 mg/dl; (7) initial result 17. 00 mg/dl, repeat 0. 11 mg/dl; (8) initial result 17. 00 mg/dl, repeat 3. 90 mg/dl; (9) initial result 17. 00 mg/dl, repeat 0. 61 mg/dl; (10) initial result 17. 00 mg/dl, repeat 0. 29 mg/dl; (11) initial result 17. 00 mg/dl, repeat 0. 20 mg/dl. No info provided to determine if results were used to guide therapy. If add'l info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-10373 |
| MDR Report Key | 958646 |
| Report Source | 05,06 |
| Date Received | 2007-11-30 |
| Date of Report | 2007-11-30 |
| Date of Event | 2007-11-14 |
| Date Facility Aware | 2007-11-14 |
| Report Date | 2007-11-14 |
| Date Mfgr Received | 2007-11-14 |
| Date Added to Maude | 2008-02-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Manufacturer G1 | HITACHI HIGH TECH CORP |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER-CEM |
| Product Code | NQD |
| Date Received | 2007-11-30 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 966464 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-30 |