MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-22 for COBAS 6000 CORE C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[16535588]
The customer received questionable phenytoin result on their c501 analyzer. Between the first and second repeat tests, the customer replaced the reagent cassette and re-calibrated the analyzer. The first patient's initial phenytoin result was 6. 2 ug/ml. The first repeat result was 24. 5 ug/ml. The second repeat result was 19. 4 ug/ml. The second patient's initial result was 3. 8 ug/ml. The first repeat result was 21. 0 ug/ml. The second repeat result was 20. 7 ug/ml. It is unknown if any of the results were reported outside the laboratory. The customer was complaining about which result was correct. It is unknown if the patients were adversely affected. The phenytoin reagent lot number was 647109 and the expiration date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[16567904]
It was unknown if the initial reporter sent report to the fda. This event occured in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[17041424]
The cause of the issue could not be determined and could not be reproduced. The issue was customer specific. The issue did not reoccur.
Patient Sequence No: 1, Text Type: N, H10
[17349612]
It was determined that the second results for the patients were reported to the physician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06879 |
| MDR Report Key | 2386817 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-22 |
| Date of Report | 2012-05-16 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-12-07 |
| Date Added to Maude | 2011-12-22 |
| 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 | 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 CORE C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2011-12-22 |
| 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 | 2011-12-22 |