ELECSYS CMV IGG

Additional Manufacturer Narrative

CALIBRATION AND QC WERE ACCEPTABLE. FOUR SAMPLES FROM THE PATIENT WERE RECEIVED FOR INVESTIGATION FROM (B)(6) 2025. THE CUSTOMER'S RESULTS WERE REPRODUCIBLE. (B)(6) 2025 (SAMPLE 1): CMV IGG: < 0.150 U/ML WITH A DATA FLAG (NEGATIVE). CMV IGM: 0.158 COI (NEGATIVE). (B)(6) 2025 (SAMPLE 2): CMV IGG: 0.694 U/ML (INDETERMINATE). CMV IGM: 34.4 COI (POSITIVE). (B)(6) 2025 (SAMPLE 3): CMV IGG: 0.266 U/ML (NEGATIVE). CMV IGM: 17.5 COI (POSITIVE). (B)(6) 2025 (SAMPLE 4): CMV IGG: 0.265 U/ML (NEGATIVE). CMV IGM: 11.7 COI (POSITIVE). THE SAMPLES WERE INVESTIGATED FURTHER. MIKROGEN RECOMLINE CMV IGG ASSAY AND IGG AVIDITY ASSAY: SAMPLE 1 WAS NEGATIVE, THERE WAS INSUFFICIENT SAMPLE VOLUME REMAINING FOR SAMPLE 2, AND SAMPLES 3 AND 4 WERE POSITIVE WITH LOW AVIDITY. PLATELIA CMV IGG ASSAY: SAMPLE 1 WAS NEGATIVE, THERE WAS INSUFFICIENT SAMPLE VOLUME REMAINING FOR SAMPLE 2, SAMPLE 3 WAS INDETERMINATE, AND SAMPLE 4 WAS POSITIVE. THE INVESTIGATION RESULTS REVEALED THAT THE SAMPLES SHOW A SEROCONVERSION UPON PRIMARY INFECTION WITH CMV, WHICH WAS CAPTURED BY THE ELECSYS CMV IGM ASSAY, BUT WAS NOT DETECTED WITH THE ELECSYS CMV IGG ASSAY. PRODUCT LABELING STATES: "ELECSYS CMV IGG RESULTS SHOULD BE USED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL SYMPTOMS, AND OTHER LABORATORY TESTS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6).

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE RESULTS FROM MULTIPLE SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE FROM (B)(6) 2025: THE CMV IGG RESULT FROM THE E801 ANALYZER WAS 0.61 U/ML (BORDERLINE). THIS SAMPLE WAS TESTED BY 2 COMPETITOR METHODS: DIASORIN LIAISON CMV IGG: 20.4 AU/ML (POSITIVE) DIASORIN LIAISON CMV IGG AVIDITY: IGG TOO LOW (AVIDITY NOT INTERPRETABLE) BIOMÉRIEUX VIDAS CMV IGG: 9 AU/ML (POSITIVE) BIOMÉRIEUX VIDAS CMV IGG AVIDITY: 8 AVI% THE RESULTS SUGGEST A RECENT PRIMARY CMV INFECTION. SAMPLE FROM (B)(6) 2025: THE CMV IGG RESULT FROM THE E801 ANALYZER WAS 0.276 U/ML (NEGATIVE). SAMPLE FROM (B)(6) 2025: ON (B)(6) 2025, THE CMV IGG RESULT WAS 0.28 U/ML (NEGATIVE). ON (B)(6) 2025, THE REPEAT RESULT WAS 0.260 U/ML (NEGATIVE). THIS SAMPLE WAS TESTED BY 2 COMPETITOR METHODS: DIASORIN LIAISON CMV IGG: 39.3 AU/ML (POSITIVE). DIASORIN LIAISON CMV IGG AVIDITY: 0.105 BIOMÉRIEUX VIDAS CMV IGG: 16 AU/ML (POSITIVE). BIOMÉRIEUX VIDAS CMV IGG AVIDITY: 28 AVI% THE RESULTS CONFIRM A RECENT PRIMARY INFECTION WITH CMV. THE CUSTOMER SUSPECTS A MISSED SEROCONVERSION OF THE ROCHE CMV IGG ASSAY.