MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-23 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1384011]
The customer alleged 43 erroneous albumin results from the cobas 6000 c501 module. The customer stated that the erroneous results were generated after encountering a problem with a reagent probe on the analyzer. The customer said that the probe was hitting the rinse station. The customer changed the probe and stated that the system ran fine all day. The erroneous results occurred after the sample probe was replaced. Repeat results were generated after servicing by the field service representative. For patient 1 the initial albumin was 0. 4 g/dl and the repeat result was 3. 7 g/dl. For patient 2 the initial albumin was 0. 3 g/dl and the repeat result was 3. 3 g/dl. For patient 3 the initial albumin was 0. 3 g/dl and the repeat result was 3. 2 g/dl. For patient 4 the initial albumin was 0. 3 g/dl and the repeat result was 2. 9 g/dl. For patient 5 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 6 the initial albumin was 0. 5 g/dl and the repeat result was 4. 6 g/dl. For patient 7 the initial albumin was 0. 5 g/dl and the repeat result was 4. 7 g/dl. For patient 8 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 9 the initial albumin was 0. 4 g/dl and the repeat result was 3. 7 g/dl. For patient 10 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 11 the initial albumin was 0. 4 g/dl and the repeat result was 3. 7 g/dl. For patient 12 the initial albumin was 0. 5 g/dl and the repeat result was 4. 6 g/dl. For patient 13 the initial albumin was 0. 2 g/dl and the repeat result was 2. 3 g/dl. For patient 14 the initial albumin was 0. 3 g/dl and the repeat result was 3. 2 g/dl. For patient 15 the initial albumin was 0. 4 g/dl and the repeat result was 3. 5 g/dl. For patient 16 the initial albumin was 0. 3 g/dl and the repeat result was 3. 1 g/dl. For patient 17 the initial albumin was 0. 3 g/dl and the repeat result was 2. 8 g/dl. For patient 18 the initial albumin was 0. 3 g/dl and the repeat result was 2. 6 g/dl. For patient 19 the initial albumin was 0. 2 g/dl and the repeat result was 1. 8 g/dl. For patient 20 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 21 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 22 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 23 the initial albumin was 0. 5 g/dl and the repeat result was 4. 5 g/dl. For patient 24 the initial albumin was 0. 4 g/dl and the repeat result was 4. 1 g/dl. For patient 25 the initial albumin was 0. 5 g/dl and the repeat result was 4. 5 g/dl. For patient 26 the initial albumin was 0. 4 g/dl and the repeat result was 3. 9 g/dl. For patient 27 the initial albumin was 0. 2 g/dl and the repeat result was 1. 9 g/dl. For patient 28 the initial albumin was 0. 3 g/dl and the repeat result was 2. 6 g/dl. For patient 29 the initial albumin was 0. 4 g/dl and the repeat result was 3. 6 g/dl. For patient 30 the initial albumin was 0. 3 g/dl and the repeat result was 3. 1 g/dl. For patient 31 the initial albumin was 0. 3 g/dl and the repeat result was 2. 8 g/dl. For patient 32 the initial albumin was 0. 3 g/dl and the repeat result was 3. 0 g/dl. For patient 33 the initial albumin was 0. 3 g/dl and the repeat result was 3. 1 g/dl. For patient 34 the initial albumin was 0. 2 g/dl and the repeat result was 2. 1 g/dl. For patient 35 the initial albumin was 0. 3 g/dl and the repeat result was 2. 5 g/dl. For patient 36 the initial albumin was 0. 2 g/dl and the repeat result was 1. 9 g/dl. For patient 37 the initial albumin was 0. 3 g/dl and the repeat result was 3. 3 g/dl. For patient 38 the initial albumin was 0. 2 g/dl and the repeat result was 1. 9 g/dl. For patient 39 the initial albumin was 0. 3 g/dl and the repeat result was 3. 1 g/dl. For patient 40 the initial albumin was 0. 2 g/dl and the repeat result was 2. 2 g/dl. For patient 41 the initial albumin was 0. 3 g/dl and the repeat result was 2. 9 g/dl. For patient 42 the initial albumin was 0. 4 g/dl and the repeat result was 3. 7 g/dl. For patient 43 the initial albumin was 0. 3 g/dl and the repeat result was 2. 6 g/dl. The albumin reagent lot number was 62566601. All initial results were reported outside the laboratory. Corrected reports were issued with the repeat results. The customer stated that no patients were affected by the erroneous results and that no change to medications or treatments occurred due to the erroneous results. The field service representative determined that there was a fluidics failure and a problem with the sample and reagent probes. The field service representative performed corrective maintenance, checked the sample and reagent probes, bleached the sample and reagent probe lines, and checked the bath water. Diagnostics and precision tests were performed and were determined to be acceptable.
Patient Sequence No: 1, Text Type: D, B5
[8720351]
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Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-05008 |
| MDR Report Key | 1810937 |
| Report Source | 05,06 |
| Date Received | 2010-08-23 |
| Date of Report | 2010-08-23 |
| Date of Event | 2010-08-10 |
| Date Mfgr Received | 2010-08-10 |
| Date Added to Maude | 2010-10-26 |
| 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 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 | CJW |
| Date Received | 2010-08-23 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2010-08-23 |