CKMB

Additional Manufacturer Narrative

THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION FOR INVESTIGATION. BASED ON THE AVAILABLE DATA, BOTH A GENERAL INSTRUMENT AND REAGENT ISSUE HAVE BEEN EXCLUDED SINCE THE SAMPLE WAS REPEATED SEVERAL TIMES AND THE QC RESULTS WERE ALWAYS ACCEPTABLE. SINCE THE CUSTOMER ONLY NOTICED THE DIFFERENCE IN RESULTS BETWEEN THE ROCHE INSTRUMENT AND THE ORTHO METHOD WITH THIS 1 PATIENT, IT IS LIKELY THE ISSUE IS RELATED TO THIS SPECIFIC PATIENT SAMPLE (E.G. AN INTERFERENT). 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). THE CUSTOMER STATED QC RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE CUSTOMER STATED THIS ISSUE WAS ONLY NOTICED WITH THIS PATIENT SAMPLE. NO OTHER PATIENT SAMPLES WERE AFFECTED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CREATINE KINASE-MB (CKMB) AND CREATINE KINASE (CK) ON A COBAS 8000 C 702 MODULE COMPARED TO THE ORTHO VITROS AND BECKMAN METHODS. THIS MEDWATCH WILL COVER CK-MB. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CK RESULTS. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(4). THE C702 MODULE SERIAL NUMBER WAS NOT PROVIDED.