MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-18 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[20215182]
The user received questionable ggt (y-glutamyltransferase) results for two samples of survey material. Of the data provided, the results for one of the samples were discrepant. The ggt result when the assay was run as part of a profile was 128 u/l and the result when the assay was run alone was 81 u/l. The user calibrated the assay, ran quality control and repeated the assay alone with a result of 85 u/l. No patient samples were involved in the event. The issue was with survey material only. The ggt reagent lot number was not provided. The field service representative determined there was a defective valve assembly and replaced it. He replaced the reagent probes, multiple valve blocks, syringe seals, rinse stations, vacuum pump, multiple sections of rinse mechanism tubing, teflon squeegees and the reaction cells and lamp. He checked all the tubing and flares for the sample probes, checked for leakage, back-flushed and cleaned the reagent and sample lines, and checked the rinse mechanism for proper operation, aspiration and dispense. He checked all rinse stations for correct water dispense and vacuum, checked detergent dispense for proper sodium concentration, back-flushed and cleaned the valves and metal elbow fittings on top of vacuum tank. He back-flushed and cleaned the rinse mechanism and all associated tubing, valves, distribution blocks and vacuum tank, checked all probe adjustments, checked rinse mechanism alignment, checked gear pump pressure several times, checked photometer readings and decontaminated the instrument. To verify the analyzer operation, the user ran calibration and quality control with all results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[20582340]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06839 |
| MDR Report Key | 1902720 |
| Report Source | 05,06 |
| Date Received | 2010-11-18 |
| Date of Report | 2010-11-18 |
| Date of Event | 2010-10-26 |
| Date Mfgr Received | 2010-10-26 |
| Date Added to Maude | 2011-04-05 |
| 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 | JQB |
| Date Received | 2010-11-18 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 | 2010-11-18 |