ELECSYS CMV IGM

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM AND ELECSYS CMV IGG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO TWO COMPETITOR METHODS. THIS MEDWATCH WILL COVER CMV IGM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CMV IGG RESULTS. THE INITIAL IGM RESULT WAS 0.22 COI, INTERPRETED AS NON-REACTIVE. THE INITIAL IGG RESULT WAS< 0.25 U/ML, INTERPRETED AS NON-REACTIVE. THE SAMPLE WAS TESTED ON A DIASORIN LIASON ANALYZER AND THE IGM RESULT WAS NON-REACTIVE, THE IGG RESULT WAS 44.5, INTERPRETED AS REACTIVE, AND THE IGG AVIDITY RESULT WAS HIGH AVIDITY. THE IGG RESULT UNITS OF MEASUREMENT WERE NOT PROVIDED. THE SAMPLE WAS ALSO TESTED ON A VIDAS BIOMÉRIEUX ANALYZER AND THE IGM RESULT WAS 3.12, INTERPRETED AS REACTIVE, THE IGG RESULT WAS 12, INTERPRETED AS REACTIVE, AND THE IGG AVIDITY RESULT WAS INTERMEDIATE AVIDITY. THE IGM AND IGG RESULTS UNITS OF MEASUREMENT WERE NOT PROVIDED.

Additional Manufacturer Narrative

NO FURTHER INFORMATION WAS PROVIDED FROM THE CUSTOMER SITE. SAMPLE MATERIAL WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.