ELECSYS CMV IGM

Additional Manufacturer Narrative

INVESTIGATION OF THE PROVIDED PATIENT SAMPLE MATERIAL FOUND THE CUSTOMER'S NON-REACTIVE ELECSYS CMV IGM RESULTS WERE REPRODUCIBLE. THE NON-REACTIVE ELECSYS CMV IGM RESULT WAS CONFIRMED BY THE RECOMLINE CMV IGM BLOT (MIKROGEN). THE INVESTIGATION DETERMINED THE SAMPLE WAS CONSISTENT WITH AN ACUTE PRIMARY CMV INFECTION (2-3 MONTHS AGO) DUE TO THE DETECTION OF LOW IGG TITERS WITH A LOW CMV IGG AVIDITY AND A DECLINING CMV IGM REACTIVITY BELOW THE BORDERLINE RANGE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL FROM THE PATENT WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FROM THE COBAS E 801 MODULE. THE ROCHE IGM RESULT WAS 0.3 (NEGATIVE) REPEATEDLY. THE BIOMERIEUX IGM RESULT WAS 1.72 (POSITIVE).