ELECSYS CMV IGM IMMUNOASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). QC RESULTS WERE WITHIN SPECIFICATION. THE LOW POSITIVE RESULTS FROM THE ABBOTT METHOD (JUST ABOVE THE CUTOFF OF 0.8) LIKELY DERIVE FROM PERSISTENT OR REACTIVATED IGM ANTIBODIES. THE HIGH CMV IGG RESULT AS WELL AS THE HIGH AVIDITY RESULT LIKELY EXCLUDE A RECENT INFECTION. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED A NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGM IMMUNOASSAY (CMV IGM) ON A COBAS 6000 E 601 MODULE. ON 03-OCT-2020 THE RESULT FROM THE E601 MODULE WAS 0.171 COI (NEGATIVE). THE SAMPLE WAS REPEATED BY THE ABBOTT METHOD WITH A RESULT OF 1.1 S/CO (POSITIVE). ON 05-OCT-2020 THE RESULT FROM THE E601 MODULE WAS 0.171 COI (NEGATIVE). THE SAMPLE WAS REPEATED BY THE ABBOTT METHOD WITH A RESULT OF 1.29 S/CO (POSITIVE). THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN REQUESTED CONFIRMATION TESTING BY THE ABBOTT METHOD. SINCE THE ABBOTT RESULTS WERE POSITIVE, ONE OF THE SAMPLES WAS SENT FOR AVIDITY TESTING (UNKNOWN METHOD) AND IT WAS HIGH (81%). THE E601 MODULE SERIAL NUMBER WAS (B)(4).