MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-08 for COBAS PHENYTOIN/200 05108411190 manufactured by Roche Diagnostics.
[17070716]
The customer received discrepant phenytoin critical results for one patient sample tested on a cobas c501 module (b)(4). The initial phenytoin result was 36. 3 ug/ml (accompanied by data flags). The sample was repeated seven times: the first repeat result was 37. 0 ug/ml (accompanied by data flags). This result was called to the physician as a critical value. The second repeat result, tested on a cobas integra 400 analyzer, gave 27. 5 ug/ml (accompanied by a data flag). The third repeat result, tested 08/21/2010 on a cobas integra 400 analyzer, gave 26. 7 ug/ml (accompanied by a data flag). The fourth repeat result, tested (b)(6)2010 on a cobas integra 400 analyzer, gave 25. 7 ug/ml (accompanied by a data flag). The fifth repeat result, tested (b)(6)2010 on a cobas integra 400 analyzer, gave 27. 3 ug/ml (accompanied by a data flag). The sixth repeat result, tested on (b)(6)2010 on original analyzer, gave 24. 9 ug/ml (accompanied by a data flag). The seventh repeat result, tested (b)(6)2010 on original analyzer, gave 25. 6 ug/ml (accompanied by a data flag). This result was called to the physician as a corrected report. The customer considered the 36. 3 ug/ml and the 37. 0 ug/ml to be erroneous results. The physician determined the two phenytoin results reported to him (37. 0 ug/ml and 25. 6 ug/ml) would be in the same range for dosing and that no change of medication was initiated based on the 37. 0 ug/ml result. The patient was not affected. The field service representative determined the phenytoin needed to be re-calibrated. He verified there were no issues with the hardware by performing mechanical checks. The field service representative also ran a precision study which was within specification. The customer re-calibrated the phenytoin and ran quality control which was acceptable.
Patient Sequence No: 1, Text Type: D, B5
[17242533]
It is unknown if the initial reporter sent a report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-05314 |
| MDR Report Key | 1827906 |
| Report Source | 05,06 |
| Date Received | 2010-09-08 |
| Date of Report | 2010-09-08 |
| Date of Event | 2010-08-19 |
| Date Mfgr Received | 2010-08-21 |
| Date Added to Maude | 2010-09-08 |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS PHENYTOIN/200 |
| Generic Name | COMPETITIVE BINDING, PHENYTOIN |
| Product Code | MOJ |
| Date Received | 2010-09-08 |
| Model Number | NA |
| Catalog Number | 05108411190 |
| Lot Number | 14827800 |
| ID Number | NA |
| Device Expiration Date | 2011-03-31 |
| 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 | 2010-09-08 |