ELECSYS CK-MB

Description of Event or Problem

THERE WAS AN ALLEGATION OF DISCREPANT HIGH CARDIAC MARKERS ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ELECSYS CK-MB ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT- (B)(6) FOR INFORMATION RELATED TO THE ELECSYS MYOGLOBIN ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-(B)(6) FOR INFORMATION RELATED TO THE ELECSYS TROPONIN T HS ASSAY. GIVEN THE DISCREPANCY BETWEEN THE HIGH CARDIAC MARKERS RESULTS AND THE NORMAL NT-PROBNP AND CARDIAC IMAGING AND CLINICAL CORRELATION, THE CUSTOMER SUSPECTS A PERSISTENT INTERFERENCE WITH THE PATIENT'S SAMPLE: THE TROPONIN T HS RESULT WAS 3486 NG/L. THE MYOGLOBIN RESULT WAS 1006 NG/ML. THE CK-MB RESULT WAS 302 NG/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER IS (B)(4). SAMPLE MATERIAL WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.