MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-01 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[19661877]
The user received questionable results for albumin generation 2 (albumin), alkaline phosphatase generation 2 and urea/bun involving three patient samples. Of the data provided, only the albumin result for one patient sample was discrepant and reported outside the laboratory. The initial albumin result was 0. 1 g/dl with a data flag and was reported outside the laboratory. The doctor questioned the result and the repeat result was 2. 5 g/dl with a data flag. The sample was repeated on another cobas c501 serial number (b)(4) and the result was 2. 6 g/dl with a data flag. The patient was not adversely affected. The albumin reagent lot number was 63305101. The field service representative determined the sample probe was not being washed properly and was not centered in rinse station. He performed a sample probe adjust and aligned rinse station. To verify the analyzer operation, the user ran quality control on all assays with results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[19748075]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-01072 |
| MDR Report Key | 2003894 |
| Report Source | 05,06 |
| Date Received | 2011-03-01 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-02-11 |
| Date Mfgr Received | 2011-02-11 |
| Date Added to Maude | 2011-03-01 |
| 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 | 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 | CIX |
| Date Received | 2011-03-01 |
| 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 | 2011-03-01 |