CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). CALIBRATION SIGNALS FROM THE LAST CALIBRATION ON (B)(6) 2024 WERE WITHIN EXPECTED RANGES. QUALITY CONTROLS RECOVERED WITHIN RANGE ON (B)(6) 2024. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTED IN A CMV IGG VALUE OF < 0.150 U/ML WITH A DATA FLAG (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER. SINCE THE PATIENT'S CMV IGG RESULT REMAINED NEGATIVE AND THE CMV IGM RESULT DECREASED, THE CUSTOMER DECIDED TO SEND THE PATIENT SAMPLE TO ANOTHER LABORATORY FOR TESTING USING THE ABBOTT METHOD. THE SAMPLE WAS TESTED USING THE ABBOTT METHOD ON (B)(6) 2024, RESULTING IN A CMV IGG VALUE OF 78.296 AU/ML (REACTIVE). THE SAMPLE WAS ALSO TESTED USING THE ABBOTT METHOD ON (B)(6) 2024, RESULTING IN A CMV IGG VALUE OF 79.520 AU/ML (REACTIVE).

Additional Manufacturer Narrative

A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE CMV IGG RESULT MEASURED BY THE CUSTOMER COULD BE REPRODUCED. SINCE THE PATIENT WAS CMV SEROPOSITIVE BEFORE THE LUNG TRANSPLANTATION, A CMV REACTIVATION OR REINFECTION APPEARS PLAUSIBLE DUE TO THE CLEAR CMV IGM REACTIVITY DETECTED IN (B)(6) 2024. IT REMAINS UNCLEAR WHY THE CMV IGG TITER IS NO LONGER DETECTABLE WITH THE ELECSYS CMV IGG ASSAY. DUE TO THE SENSITIVITY AS CLAIMED IN THE PRODUCT LABELING, SINGLE FALSE NEGATIVES CAN OCCUR. A GENERAL PRODUCT PROBLEM WAS NOT FOUND. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.