MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-17 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[16838812]
The user received questionable results for total protein generation 2 (tp2) on the cobas c501 analyzer. The event involved 7 patient samples which gave discrepant results. The patient samples were repeated on (b)(6) 2010 and were run on a different c501 analyzer serial number (b)(4). Patient sample 1, the initial result was 2. 3 g/dl; the repeat result was 8. 4 g/dl. Patient sample 2, the initial result was 2. 3 g/dl; the repeat result was 7. 7 g/dl. Patient sample 3, the initial result was 2. 3 g/dl; the repeat result was 6. 7 g/dl. Patient sample 4, the initial result was 2. 4 g/dl; the repeat result was 8. 3 g/dl. Patient sample 5, the initial result was 2. 4 g/dl; the repeat result was 5. 4 g/dl. Patient sample 6, the initial result was 2. 3 g/dl; the repeat result was 5. 7 g/dl. Patient sample 7, the initial result was 2. 4 g/dl; the repeat result was 7. 4 g/dl. The initial results were reported outside the laboratory to the physicians and required corrected reports to be generated. The patients did not receive any treatment and were not affected by this event. The reagent lot number for tp2 was not provided. The field service representative found an issue with the gear pump. He adjusted gear pump pressures. Performance tests were run which were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[17010653]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06794 |
| MDR Report Key | 1901377 |
| Report Source | 05,06 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-11-17 |
| Date of Event | 2010-11-01 |
| Date Mfgr Received | 2010-11-02 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEK |
| Date Received | 2010-11-17 |
| 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 | 2010-11-17 |