ELECSYS CK-MB STAT IMMUNOASSAY

Additional Manufacturer Narrative

THERE WAS NO REMAINING SAMPLE VOLUME AVAILABLE TO INVESTIGATE THE DISCREPANCY IN CK-MB VALUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CK-MB STAT IMMUNOASSAY ON A COBAS 8000 E 602 MODULE. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE RESULTED WITH A CK-MB VALUE OF 240.9, AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO A PHYSICIAN. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING ON AN ORTHO VITROS ANALYZER AND AN ABBOTT ARCHITECT ANALYZER. BOTH COMPETITOR ANALYZERS RESULTED WITH "NEGATIVE" CK-MB VALUES. NO SPECIFIC VALUES WERE PROVIDED FOR THESE COMPETITOR RESULTS. THE REPORTER STATED THAT THIS PATIENT HAS HAD CONSISTENTLY HIGH CK-MB RESULTS FOR APPROXIMATELY 10 SAMPLES THAT HAVE BEEN COLLECTED SINCE (B)(6) 2020. THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(4).