MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for ELECSYS CK-MB STAT IMMUNOASSAY 05894808190 manufactured by Roche Diagnostics.
[85776891]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[85776892]
The customer noticed a shift in elecsys ck-mb immunoassay results for qc and patient samples when putting reagent lot 222123 into use. The customer performed a patient comparison and of the data provided for 13 patient samples, only the results for two patient samples were discrepant. Patient 1 original result with an unknown lot number was 22. With reagent lot 222123, the result was 27. With reagent lot 164858, the result was 22. Patient 2 original result with an unknown lot number was 130. With reagent lot 222123, the result was 150. With reagent lot 164858, the result was 120. The unit of measure was requested but was not provided. Information concerning if any erroneous result was reported outside of the laboratory or if any patient was adversely affected was requested, but it was not provided. The customer used cobas 6000 e 601 module serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01883 |
| MDR Report Key | 6837422 |
| Date Received | 2017-09-01 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-09-01 |
| 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 | 0 |
| Brand Name | ELECSYS CK-MB STAT IMMUNOASSAY |
| Generic Name | COLORIMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHY |
| Date Received | 2017-09-01 |
| Model Number | NA |
| Catalog Number | 05894808190 |
| Lot Number | 222123 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-01 |