MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-12-01 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[17894991]
The field application specialist reported the user failed a proficiency survey for total protein urine/csf generation 3 (total protein) for two of three urine samples. Of the data provided, the results for one sample were discrepant. The original result was 97. 2 mg/dl. The repeat result on cobas c501 serial number (b)(4) was 50. 8 mg/dl. On (b)(6) 2010, the repeat result on the original instrument was 48. 5 mg/dl. The survey acceptable range was 43-53 mg/dl with a mean of 48 mg/dl. No patients were involved in the event. The issue was with proficiency material only. The total protein reagent lot number was 62675101. The user declined a service visit as the instrument was running properly. The field application specialist determined the cause was unknown and stated she suspected a sampling issue with the samples or the instrument.
Patient Sequence No: 1, Text Type: D, B5
[17913310]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07067 |
| MDR Report Key | 1911684 |
| Report Source | 05,06,07 |
| Date Received | 2010-12-01 |
| Date of Report | 2010-12-01 |
| Date of Event | 2010-10-01 |
| Date Mfgr Received | 2010-11-12 |
| Date Added to Maude | 2010-12-08 |
| 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 | 2010-12-01 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-12-01 |