MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-08-29 for COBAS CEDIA CARBAMAZEPINE 04874625190 manufactured by Roche Diagnostics.
[2991492]
The customer alleged they received questionable carbamazepine results on their cobas 8000 c502 module, serial number (b)(4). The customer provided data for three patients, of which two had discrepant results that were reported outside the laboratory. The customer told the field application specialist (fas) that their carbamazepine quality control was trending down every 2-3 of days. The fas was told that remixing the reagent cassette and repeating quality control did not help, but recalibrating did improve the quality control. Repeat testing was performed on the same analyzer as the initial testing. Both patients received doses of carbamazepine in the morning and had their blood drawn in the early afternoon. The first patient had an initial carbamazepine result of 10. 0 ug/ml. The corrected result of 12. 4 ug/ml was reported on (b)(6) 2012. The second patient, a male born on (b)(6) 1952, had an initial carbamazepine result of 10. 1 ug/ml. The corrected result of 13. 2 ug/ml was reported on (b)(6) 2012. The customer was not aware of any adverse affects to any patients due to the erroneous carbamazepine results being reported. The customer thought this event was a reagent settling issue and declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[10156395]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10243378]
For the investigation, retention cassettes for carb lots 660271 and 667123 were calibrated on a c502 analyzer and tdm controls were measured over a period of 14 days. The issue the customer saw could not be veriifed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-04373 |
| MDR Report Key | 2718882 |
| Report Source | 05,06,07 |
| Date Received | 2012-08-29 |
| Date of Report | 2012-10-24 |
| Date of Event | 2012-07-13 |
| Date Mfgr Received | 2012-08-07 |
| Date Added to Maude | 2012-08-29 |
| 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 | COBAS CEDIA CARBAMAZEPINE |
| Generic Name | ENZYME IMMUNOASSAY, CARBAMAZEPINE |
| Product Code | KLT |
| Date Received | 2012-08-29 |
| Model Number | NA |
| Catalog Number | 04874625190 |
| Lot Number | 66027101 |
| ID Number | NA |
| Device Expiration Date | 2013-06-30 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-29 |