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 2015-05-06 for COBAS E-ELECSYS CK-MB STAT GEN 4 05957648160 manufactured by Roche Diagnostics.
[16176446]
The customer received questionable ckmb stat (ck-mb - the mb isoenzyme of creatine kinase) results for 27 patient samples on cobas e601 analyzer serial number (b)(4) on (b)(6) 2015. The customer noticed low results for patient samples and performed a calibration which failed on the active reagent pack, but was acceptable on the standby reagent pack. The customer removed the active pack and repeated patient testing using the standby reagent pack. Of the data provided, only the results for three patient samples from (b)(6) 2015 were a reportable malfunction. Patient sample 1 initial result was 1. 62 ng/ml. Patient sample 2 initial result was 0. 969 ng/ml. Patient sample 3 initial result was 1. 37 ng/ml. The repeat results were requested, but not provided. The initial results were reported outside the laboratory. The patients were not adversely affected. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The suspect reagent pack was checked and beads were found in the inner cover. An issue with the single reagent pack at the site was the most probable cause.
Patient Sequence No: 1, Text Type: D, B5
[16349455]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03426 |
| MDR Report Key | 4752922 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-04-25 |
| Date Added to Maude | 2015-05-06 |
| 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 | COBAS E-ELECSYS CK-MB STAT GEN 4 |
| Generic Name | COLORIMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHY |
| Date Received | 2015-05-06 |
| Model Number | NA |
| Catalog Number | 05957648160 |
| Lot Number | 180298 |
| ID Number | NA |
| 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 | 2015-05-06 |