ELECSYS CK-MB STAT IMMUNOASSAY
Received Jan 29, 2019
Report 1823260-2019-90066 · MDR key 8284597
Device
Generic name
Colorimetric Method, Cpk Or Isoenzymes
Manufacturer
Roche DiagnosticsModel number
CK-MB STATLot number
297009
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOW UP/CORRECTIVE ACTIONS WERE THAT THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. HIGH RESULTS WERE GENERATED BY THE COBAS 6000 E 601 MODULE. THE EVENT INVOLVED A TOTAL OF 1 PATIENT WITH HIGH RESULTS FOR THE ELECSYS CK-MB STAT IMMUNOASSAY. THE PATIENT AGE WAS (B)(6). THE PATIENT WEIGHT WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT GENDER WAS FEMALE. THE PATIENT'S RACE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT WAS NOT PROVIDED.