MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-26 for COBAS 6000 CORE 05036453001 manufactured by Roche Diagnostics.
[1946163]
The customer stated they were receiving questionable results for ammonia on their cobas c501 for one patient. There were three discrepant results and one result was reported outside the laboratory. The tests were all performed on the same analyzer. The initial result was -39. 4 umol/l accompanied by a data flag. The second result was 11. 3 umol/l accompanied by a data flag. The third result was 50. 6 umol/l performed on a 1:3 dilution and this result was reported outside the laboratory. There was no adverse affect to the patient due to this event. The reagent lot number for the ammonia was not provided. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[9109135]
.
Patient Sequence No: 1, Text Type: N, H10
[9120751]
Roche trains operators to perform an increased or decreased sample volume rather than dilution for ammonia assays when the result is above the test range. The laboratory technician who performed the dilution was retrained on the use of dilution orders for this analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02268 |
| MDR Report Key | 2069790 |
| Report Source | 05,06 |
| Date Received | 2011-04-26 |
| Date of Report | 2011-05-20 |
| Date of Event | 2011-04-02 |
| Date Mfgr Received | 2011-04-02 |
| Date Added to Maude | 2011-04-26 |
| 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 | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2011-04-26 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-26 |