ELECSYS CMV IGM

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THEY RECEIVED DISCREPANT CMV IGM RESULTS FOR A THIRD PATIENT SAMPLE. THIS THIRD SAMPLE HAS A NON-REACTIVE CMV IGM RESULT WHEN TESTED WITH THE ROCHE METHOD AND A REACTIVE RESULT WHEN TESTED WITH THE COMPETITOR METHOD (ABBOTT ALINITY). CALIBRATION SIGNALS FROM 25-SEP-2023 WERE WITHIN EXPECTED RANGES. QUALITY CONTROLS MEASURED ON THE DAY OF THE EVENT WERE WITHIN RANGE. THE PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. THE FIRST AND THIRD SAMPLES WERE DETERMINED TO BE NON-REACTIVE WITH THE CMV IGM ASSAY AND WERE NO IN ACCORDANCE WITH REACTIVE RESULTS FROM ANOTHER MANUFACTURER. ADDITIONAL ANALYSES SHOWED THAT THESE SAMPLES CONTAINED CMV-SPECIFIC IGG ANTIBODIES OF HIGH AVIDITY, SUGGESTING OTHER METHODS MAY DETECT PERSISTING CMV IGM ANTIBODIES IN THESE SAMPLES. OVERALL, THE RESULTS DO NOT INDICATE AN EARLY PHASE OF INFECTION WITH CMV. FOR SAMPLE 2, THE MAJORITY OF METHODS DELIVERED NON-REACTIVE CMV IGM AND IGG RESULTS. THE PATIENT IS CONSIDERED SERONEGATIVE FOR CMV. THE INVESTIGATION DETERMINED THE CMV IGM ASSAY PERFORMS WITHIN SPECIFICATION.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS CMV IGM ON A COBAS E 801 ANALYTICAL UNIT IN COMPARISON TO RESULTS MEASURED WITH A COMPETITOR METHOD. THE FIRST SAMPLE WAS TESTED WITH THE COMPETITOR METHOD ON (B)(6) 2023, RESULTING IN A CMV IGM VALUE OF 1.51 INDEX (REACTIVE). THE FIRST SAMPLE RESULTED IN A CMV IGM VALUE OF 0.568 COI (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2023. THE SECOND SAMPLE WAS TESTED WITH THE COMPETITOR METHOD ON (B)(6) 2023, RESULTING IN A CMV IGM VALUE OF 1.76 INDEX (REACTIVE). THE FIRST SAMPLE RESULTED IN A CMV IGM VALUE OF 0.221 COI (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2023.