CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION AND THE RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED. FOR HALF THE SAMPLES, THERE IS CLEAR EVIDENCE OF CMV IGG REACTIVITY. A PAST CMV INFECTION STATUS IS SUGGESTED DUE TO THE HIGH AVIDITY OF IGG ANTIBODIES IN COMBINATION WITH THE ABSENCE OF CMV IGM REACTIVITY. FOR SOME SAMPLES, CMV IGG REACTIVITY APPEARS LIKELY, ALTHOUGH THE STATUS OF THE PATIENTS COULD NOT BE COMPLETELY RESOLVED. THESE SAMPLE IDS ARE THE FOLLOWING: (B)(6). FOR THE MINORITY OF SAMPLES, A FALSE REACTIVE RESULT IN THE ELECSYS CMV IGG ASSAY CANNOT BE EXCLUDED. THESE SAMPLE IDS ARE THE FOLLOWING: (B)(6). GIVEN THE UNCLEAR SEROLOGIC PATTERNS OF SOME PATIENTS, IT IS RECOMMENDED TO CONSIDER THESE TWO PATIENTS SERONEGATIVE FOR CMV. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6) . THE PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. ALL PROVIDED QUALITY CONTROL DATA WAS WITHIN RANGE. THE COMPETITOR ASSAY IS FROM ABBOTT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED FALSE POSITIVE RESULTS FOR 20 PATIENT SAMPLES TESTED WITH CMV IGG ELECSYS E2G ON A COBAS E 801 ANALYTICAL UNIT. THE RESULTS FROM THE ROCHE ASSAY WERE REACTIVE, WHILE THE RESULTS FROM A COMPETITOR ASSAY WERE NON-REACTIVE. SEE THE ATTACHMENT FOR ALL PATIENT DATA. ALL ROCHE RESULTS ARE INTERPRETED AS REACTIVE. ALL COMPETITOR RESULTS ARE INTERPRETED AS NON-REACTIVE.