MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-22 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[16114798]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[16171594]
The customer alleged a discrepant albumin result on a patient. The customer obtained the following albumin results on the specimen: initial albumin = 5. 8 g/dl repeat #1 = 5. 9 g/dl repeat #2 (diluted) = 6. 9 g/dl albumin 2 reagent lot #: 61868401 the customer stated that the results were not reported outside the laboratory. There was no report of death or serious injury in connection with this discrepancy. The field service representative determined that the r2 mixer was damaged. He replaced the mixer. The customer successfully calibrated and quality control specimens yielded acceptable results. The customer reran the specimen: initial albumin (after repair) = 5. 9 g/dl repeat (diluted) = 6. 1 g/dl, these results were acceptable. A precision check was also performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2010-02395 |
| MDR Report Key | 1664602 |
| Report Source | 05,06 |
| Date Received | 2010-04-22 |
| Date of Report | 2010-04-22 |
| Date of Event | 2010-04-06 |
| Date Mfgr Received | 2010-04-06 |
| Date Added to Maude | 2010-04-22 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIX |
| Date Received | 2010-04-22 |
| 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 | 2010-04-22 |