CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE SAMPLE FROM ON (B)(6) 2023 WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS TESTED WITH CMV IGG REAGENT LOT: 634409 ON A COBAS E801 MODULE: 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED WITH CMV IGM REAGENT LOT: 663940 ON A COBAS E801 MODULE: 0.168 COI (NON-REACTIVE). THE CUSTOMER'S CMV IGG AND CMV IGM RESULTS WERE REPRODUCED. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

SECTION A3 WAS UPDATED. CALIBRATION WAS ACCEPTABLE. THE SAMPLE WAS INVESTIGATED FURTHER USING THE RECOMLINE CMV IGM AND IGG BLOT (MIKROGEN) METHODS AND THE SAMPLE WAS CONFIRMED AS NON-REACTIVE. BASED ON THE INVESTIGATION RESULTS, THE PATIENT IS BELIEVED TO BE SERONEGATIVE FOR CMV. A GENERAL PRODUCT PROBLEM WAS NOT FOUND. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT NON-REACTIVE RESULTS FOR TWO SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS CMV IGG ASSAY ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER (B)(6)) AND COMPARED TO COMPETITOR METHODS. FIRST SAMPLE FROM (B)(6) 2023: THE SAMPLE RESULTED IN A CMV IGG VALUE OF < 0.150 (NON-REACTIVE). THE SAMPLE WAS REPEATED USING THE ABBOTT ARCHITECT CMV IGG METHOD, RESULTING IN A VALUE OF 22.73 UA/ML (REACTIVE). SECOND SAMPLE FROM (B)(6) 2023: THE SAMPLE RESULTED IN A CMV IGG VALUE OF < 0.150 (NON-REACTIVE). THE SAMPLE WAS REPEATED USING THE ABBOTT ARCHITECT CMV IGG METHOD, RESULTING IN A VALUE OF 21.69 UA/ML (REACTIVE). A SAMPLE FROM THE PATIENT WAS ALSO TESTED USING THE VIDAS CMV IGG METHOD, RESULTING IN INDEX 7 (REACTIVE). IT IS UNKNOWN WHICH SAMPLE WAS USED FOR TESTING. A SAMPLE FROM THE PATIENT WAS ALSO TESTED USING THE DIASORIN CMV IGG METHOD, RESULTING IN INDEX 22 (REACTIVE). IT IS UNKNOWN WHICH SAMPLE WAS USED FOR TESTING. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE SAMPLES WERE REQUESTED FOR INVESTIGATION. H3 OTHER TEXT : NA.