MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-01 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[9122703]
A specific root cause could not be identified. It was noted the customer was using 13 mm diameter tubes without tube adapters. Due to insufficient data, no further investigation was possible. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
[16118890]
.
Patient Sequence No: 1, Text Type: N, H10
[21977022]
.
Patient Sequence No: 1, Text Type: N, H10
[22095413]
The customer has been receiving questionably low results for multiple reagents on their cobas c501 analyzer. The customer received a discrepant albumin gen. 2 result that was reported outside the laboratory. The customer repeated the test on the same analyzer and reported those results outside the laboratory. The initial result was 0. 1g/dl. The repeat result was 4. 4 g/dl. The patient was not adversely affected by this event. The lot number of the reagent was not provided. The field service representative was unable to determine the cause of this event. He cleaned and checked the sample alignment of the probes. He ran precision check on the analyzer with passing results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2011-01827 |
| MDR Report Key | 2036611 |
| Report Source | 05,06 |
| Date Received | 2011-04-01 |
| Date of Report | 2011-06-22 |
| Date of Event | 2011-03-14 |
| Date Mfgr Received | 2011-03-18 |
| Date Added to Maude | 2011-04-01 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| 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 | COBAS 6000 C501 MODULE |
| Product Code | CJW |
| Date Received | 2011-04-01 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-04-01 |