MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-09 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[18080482]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[18237858]
The user received questionable results for multiple assays over time and provided an example of creatine kinase (ck) results for one patient sample. The initial result was 61 u/l with a data flag and the repeat result was 78 u/l with a data flag. The sample was retested with a dilution and the result was greater than 30% different from the original and first repeat result. The user could not provide the specific result. The erroneous result was reported outside the laboratory. The patient was not adversely affected. The ck reagent lot number was 63315601. The user declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2011-00707 |
| MDR Report Key | 1982215 |
| Report Source | 05,06 |
| Date Received | 2011-02-09 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-01-21 |
| Date Mfgr Received | 2011-01-21 |
| Date Added to Maude | 2011-02-09 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2011-02-09 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-02-09 |