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 2018-04-03 for ELECSYS CK-MB STAT IMMUNOASSAY 05957648190 manufactured by Roche Diagnostics.
[104426588]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[104426589]
The customer received questionable elecsys ck-mb stat immunoassay results when comparing reagent lots. Of the data provided, only the results for one patient sample were discrepant. The result with reagent lot 222122 was 58 ng/ml and the result with reagent lot 297009 was 49. 98 ng/ml. The results with reagent lot 222122 had been released outside of the laboratory to medical personnel. When the samples were repeated with the new reagent lot, those results were seen as erroneous and were not released. There was no allegation of an adverse event. The type and serial number of analyzer used for the testing was requested but was not provided. The investigation was unable to find a definitive root cause. An issue with the single reagent pack was suspected by the customer as there were microparticles in the lid most likely due to transportation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01005 |
| MDR Report Key | 7391506 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-03 |
| 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 | 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 | ELECSYS CK-MB STAT IMMUNOASSAY |
| Generic Name | COLORIMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHY |
| Date Received | 2018-04-03 |
| Model Number | NA |
| Catalog Number | 05957648190 |
| Lot Number | 297009 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-03 |