ELECSYS CK-MB IMMUNOASSAY
Received Dec 19, 2018 · Event occurred Dec 6, 2018
Report 1823260-2018-05004 · MDR key 8178956
Device
Generic name
Colorimetric Method, Cpk Or Isoenzymes
Manufacturer
Roche DiagnosticsModel number
NACatalog number
ASKU
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
52 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
THE CUSTOMER CONSISTENTLY RECEIVED QUESTIONABLE HIGH TROPONIN T HS, CREATINE KINASE (CK), AND ELECSYS CK-MB IMMUNOASSAY RESULTS FOR ONE PATIENT FROM THE COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR CK-MB. REFER TO THE MEDWATCHS WITH PATIENT IDENTIFIERS (B)(6) AND (B)(6) FOR THE OTHER ASSAYS. THE DOCTOR BELIEVED THE RESULT WERE AN "IMPLAUSIBLE CONSTELLATION OF CARDIAC MARKERS IN CASE OF A SHOWING NO CARDIAC SYMPTOMS". THERE WAS NO EVIDENCE OF AN ACUTE MYOCARDIAL INFARCT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER SUSPECTED A NON-CARDIAC ISOFORM OF TROPONIN T WAS PRESENT.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.