MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-08-07 for ONLINE TDM CARBAMAZEPINE GEN.4 CARB G4 07258062190 manufactured by Roche Diagnostics.
[153824434]
The investigation believes there is an interferent present affecting the carb4 results from the cobas c501. The patient samples were provided for further investigation. The investigation is currently ongoing. The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[153824435]
The initial reporter complained of questionable carb4 carbamazepine results for 1 patient tested on a cobas 6000 c (501) module compared to the carb carbamazepine result from a cobas integra 400 plus. The initial reporter believes the carb4 results are not matching the treatment of the patient. The initial carb4 result from the cobas c501 for a patient under carbamezepine treatment was < 2. 00 ug/ml with a data flag. On (b)(6) 2019 the physician took samples both before and after treatment and the carb4 results from the cobas c501 were < 2. 00 ug/ml with a data flag and < 2. 00 ug/ml with a data flag. The patient samples were sent to another site and tested on a integra 400. The carb results were positive for the samples collected after treatment. The specific results were not provided. The cobas c501 serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-02868 |
| MDR Report Key | 8868703 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-06-24 |
| Date Mfgr Received | 2019-07-12 |
| Date Added to Maude | 2019-08-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONLINE TDM CARBAMAZEPINE GEN.4 |
| Generic Name | CARBAMAZEPINE ENZYME IMMUNOASSAY |
| Product Code | KLT |
| Date Received | 2019-08-07 |
| Model Number | CARB G4 |
| Catalog Number | 07258062190 |
| Lot Number | 364239 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-07 |