MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-25 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1902645]
The customer received questionable ammonia results for one patient sample. The initial result was 401 umol/l and was reported outside the laboratory. The sample was repeated on this cobas 6000 c501 analyzer which recovered 51 umol/l. The sample was repeated again on another cobas 6000 c501 analyzer (serial number (b)(4)) and recovered 27 umol/l. The customer immediately reported the correct result of 27 umol/l result to the nurse. The nurse had not seen the initial ammonia result. The patient was not adversely affected. The ammonia reagent lot number was 62961001. The field service representative and the field application specialist determined the external probe rinse water was low which did not allow for adequate rinsing of the r2 probe. The field service representative adjusted the washing mechanism and repeated the patient samples. The patient results were acceptable. The customer ran quality control which recovered within established ranges.
Patient Sequence No: 1, Text Type: D, B5
[8973190]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00387 |
| MDR Report Key | 1970524 |
| Report Source | 05,06 |
| Date Received | 2011-01-25 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-06 |
| Date Mfgr Received | 2011-01-06 |
| Date Added to Maude | 2011-04-07 |
| 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 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2011-01-25 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-01-25 |