MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-11-15 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1668997]
The user received questionable results for one patient sample while performing a comparison of at least 12 samples using different versions of the ferritin assay. With the ferritin generation 3 reagent the result was 135 ug/l and with the ferritin generation 4 reagent the result was 14. 3 ug/l. The results were not reported outside the laboratory as the samples were tested for comparison only. No adverse events were alleged regarding the issue. The patient's current condition was "good". The ferritin generation 3 reagent lot number was 625157 and the ferritin generation 4 reagent lot number was 627701.
Patient Sequence No: 1, Text Type: D, B5
[8816391]
The sample was provided for investigation. The sample was tested using a cobas c501, using ferrtin reagent generation 3 and ferritin reagent generation 4. The sample was also tested on the elecsys e411 analyzer, the results from the ferritin generation 4 assay were consistent to the ferritin result on the elecsys e411. The result from the generation 4 assay should be reliable. The root cause for the different recoveries between ferritin generation 3 and ferritin generation 4 assays on the cobas c501 instrument may be a sample specific effect, most likely related to an enzymatic cleavage process, however this could not be confirmed. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
[8980561]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06730 |
| MDR Report Key | 1898679 |
| Report Source | 01,05,06 |
| Date Received | 2010-11-15 |
| Date of Report | 2011-01-07 |
| Date of Event | 2010-10-21 |
| Date Mfgr Received | 2010-10-21 |
| Date Added to Maude | 2011-04-07 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2010-11-15 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 | 2010-11-15 |