MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-22 for ALBUMIN GEN.2 03183688122 manufactured by Roche Diagnostics.
[2140017]
The customer received questionable results for multiple assays for approximately 15 patients when tested on a cobas 6000 c501 module, serial number (b)(4). The assays included albumin (generation 2), creatinine kinase, creatinine (jaffe generation 2), alkaline phosphatase, hdl-cholesterol and magnesium. The initial results were reported outside the laboratory and the customer sent approximately 39 corrected reports. The customer received high albumin results for an unknown number of patient samples. The customer provided one example which initially recovered around 5. 8 g/dl and when repeated on another cobas 6000 c501 analyzer generated 4. 2 g/dl. No adverse events have been alleged regarding the discrepancies. The field service representative determined a defective valve on the valve bank av2 was the cause and he replaced the valve bank av2. The field service representative tested the replacement valve and verified the instrument was operating within specifications.
Patient Sequence No: 1, Text Type: D, B5
[9139609]
.
Patient Sequence No: 1, Text Type: N, H10
[9466641]
Further investigation of the event could not clearly identify a specific root cause as the customer refused to provide further data for the additional evaluation. The problem was solved by the appropriate troubleshooting process where it was found there was a dilution of the reaction by a leaking r2 nozzle, av2 valve block and r2 nozzle. These parts were replaced during the service visit. As far as it was known, no patients were adversely affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03897 |
| MDR Report Key | 2171733 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-06-28 |
| Date Mfgr Received | 2011-06-28 |
| Date Added to Maude | 2011-07-22 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 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 | ALBUMIN GEN.2 |
| Generic Name | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Product Code | CIX |
| Date Received | 2011-07-22 |
| Model Number | NA |
| Catalog Number | 03183688122 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-07-22 |