MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-19 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[16424440]
.
Patient Sequence No: 1, Text Type: N, H10
[16636208]
The customer received very high ammonia results for one patient sample, she reran the sample when she saw the high result. The initial ammonia result was 335 umol/l (accompanied by a data flag). The sample, repeated on another cobas 6000 c501 module (serial number (b)(4)), gave an ammonia result of 67 umol/l (accompanied by a data flag). The sample, repeated on this cobas c501 module (serial number (b)(4)), gave an ammonia result of 65 umol/l (accompanied by a data flag). The initial result was reported outside the laboratory for this outpatient sample, however, the result was corrected prior to the doctor viewing it. The patient was not affected by the erroneous result. The ammonia reagent lot was 61651401. The field service representative determined the sample probe needed to be flushed and he flushed the sample probe and the primary line. The field service representative also replaced all the seals and squeegees and ran performance tests. Calibration and quality control were also performed and were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2010-04977 |
| MDR Report Key | 1808342 |
| Report Source | 05,06 |
| Date Received | 2010-08-19 |
| Date of Report | 2010-08-19 |
| 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 |
| 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 | 2010-08-19 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2010-08-19 |