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 2014-06-12 for COBAS E411 SYSTEM manufactured by Roche Diagnostics.
[4457687]
The customer received questionable ck-mb - the mb isoenzyme of creatine kinase stat and troponin i stat results for one patient. The initial ckmb result was 300 ng/ml with a data flag. The initial troponin i result was 25. 00 ng/ml with a data flag. The repeat ckmb result when diluted 1:10 was 41. 28 ng/ml with a data flag. The repeat troponin i result when diluted 1:10 was 23. 21 ng/ml with a data flag. These results were reported outside the laboratory. The second repeat ckmb result when diluted 1:10 was 404. 7 ng/ml with a data flag. The second repeat troponin i result when diluted 1:10 was 197. 9 ng/ml with a data flag. These results were reported outside the laboratory. The patient was not adversely affected. The ckmb reagent lot number was 174105 and the troponin i reagent lot number was 174423. The expiration dates were requested, but were not provided.
Patient Sequence No: 1, Text Type: D, B5
[11914962]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the provided calibration data, general reagent issues were not suspected.
Patient Sequence No: 1, Text Type: N, H10
[12092216]
Information concerning the specific part number involved in this event was requested, but was not provided. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-04299 |
| MDR Report Key | 3869460 |
| Report Source | 01,05,06 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-07-15 |
| Date of Event | 2014-05-22 |
| Date Mfgr Received | 2014-06-01 |
| Date Added to Maude | 2014-06-12 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| 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 E411 SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2014-06-12 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2014-06-12 |