CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION WAS ABLE TO CONFIRM THE CUSTOMER'S REACTIVE ELECSYS CMV IGG RESULTS. EVIDENCE OF A PREVIOUS INFECTION IS SUPPORTED BY THE INVESTIGATIONAL NON-REACTIVE ELECSYS CMV IGM RESULTS AND HIGH ELECSYS CMV IGG AVIDITY RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THREE OTHER COMPETITOR ASSAYS. THE INITIAL CMV IGG RESULT WAS 11.9 UI/ML, INTERPRETED AS REACTIVE. THE SAMPLE WAS REPEATED ON THREE COMPETITOR ASSAYS. THE ABBOTT ALINITY RESULT WAS LESS THAN 6 UI/ML, INTERPRETED AS NON-REACTIVE. THE DIASORIN LIASON RESULT WAS LESS THAN 6 UI/ML, INTERPRETED AS NON-REACTIVE. THE BIOMERIEUX RESULT WAS LESS THAN 15 UI/ML, INTERPRETED AS NON-REACTIVE.

Additional Manufacturer Narrative

IT WAS ALLEGED THAT A RECEIVER OF THE BLOOD DONATION FROM THE PATIENT RECEIVED PRE-EMPTIVE TREATMENT BASED ON THE INITIAL REACTIVE CMV IGG RESULT. THERE WAS NO ALLEGATION OF ANY HARM. THE ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION FOUND THAT THE REACTIVE ROCHE CMV IGG RESULTS COULD BE REPRODUCED. THE INVESTIGATION IS ONGOING.