MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-18 for CEDIA CARBAMAZEPINE ASSAY 04874625190 manufactured by Roche Diagnostics.
[16972659]
The investigation could not determine a specific root cause. The data provided was evaluated and a system issue could be excluded and a reagent issue was not considered likely. The most probable root cause is a pre-analytical issue related to insufficient sample pipetting.
Patient Sequence No: 1, Text Type: N, H10
[21728529]
The customer received questionable results for carbamazepine (carb) on three patient samples. Of those three, it was determined one sample had erroneous results that had been reported outside of the laboratory. The customer indicated they had qc imprecision for carb since beginning a new lot of reagent in february. The customer indicated they've only experienced this qc imprecision/drift with the most recent lot of reagent. The customer was able to borrow a different lot of carb reagent to perform a patient comparison. The initial carb result with this current lot was 3. 8 ug/ml, accompanied by a data flag, which was reported outside of the laboratory. The sample was repeated on the same instrument with the borrowed carb reagent and generated a repeat result of 5. 5 ug/ml. The customer deemed the repeat result to be the correct result and was going to issue a corrected report. There was no treatment received based on the reported results. There was no adverse event. The cobas 6000 c501 instrument with serial number (b)(4) was used to generate the results. The lot number for the borrowed carb reagent was 68535101, with an expiration date of 04/30/2014. The field service representative indicated there was an issue with the reagent. He checked the fluidics system and adjusted the cuvette rinse water level and adjusted the reagent probe rinse volumes. He checked the gear pump pressure, probe alignment and photometer absorbance, all of which were ok. He performed a mechanism check and found no problems. He performed a precision check on carb, which passed. The customer performed calibration and controls to their specification.
Patient Sequence No: 1, Text Type: D, B5
[22089070]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02858 |
| MDR Report Key | 3759395 |
| Report Source | 05,06 |
| Date Received | 2014-04-18 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-03-28 |
| Date Added to Maude | 2014-04-18 |
| 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 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 | CEDIA CARBAMAZEPINE ASSAY |
| Generic Name | ENZYME IMMUNOASSAY, CARBAMAZEPINE |
| Product Code | KLT |
| Date Received | 2014-04-18 |
| Model Number | NA |
| Catalog Number | 04874625190 |
| Lot Number | 68990501 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| 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 | 2014-04-18 |