ELECSYS CMV IGG

Additional Manufacturer Narrative

ADDITIONAL INVESTIGATION RESULTS: SAMPLE 1: THE MIKROGEN RECOMLINE'S METHOD CMV IGG RESULT WAS REACTIVE. THE MIKROGEN RECOMLINE'S METHOD CMV IGM RESULT WAS REACTIVE. SAMPLE 2: THE MIKROGEN RECOMLINE'S METHOD CMV IGG RESULT WAS REACTIVE. THE MIKROGEN RECOMLINE'S METHOD CMV IGM RESULT WAS REACTIVE. THE CUSTOMER'S RESULTS WERE REPRODUCED. AN ACUTE PRIMARY INFECTION IS INDICATED IN THIS CASE. THE ELECSYS CMV IGM ASSAY DETECTED THE ACUTE CMV INFECTION. HOWEVER, A SEROCONVERSION TO IGG IS NOT YET DETECTED BY THE ELECSYS CMV IGG ASSAY IN CONTRAST TO TWO COMPETITOR ASSAYS. DUE TO THE SENSITIVITY CLAIMED IN PRODUCT LABELING, SINGLE FALSE NEGATIVES CAN OCCUR. THE REAGENT PERFORMS WITHIN SPECIFICATION. PRODUCT LABELING STATES: "A NEGATIVE TEST RESULT DOES NOT COMPLETELY RULE OUT THE POSSIBILITY OF AN INFECTION WITH CMV. INDIVIDUALS MAY NOT EXHIBIT ANY DETECTABLE IGG ANTIBODIES AT THE EARLY STAGE OF ACUTE INFECTION." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CUSTOMER'S CALIBRATION WAS WITHIN EXPECTED RANGES. THE SAMPLES WERE RETURNED FOR INVESTIGATION. INVESTIGATION RESULTS: SAMPLE 1: THE ELECSYS CMV IGM RESULT WAS 1.03 COI (REACTIVE). THE ELECSYS CMV IGG RESULT WAS 0.150 U/ML (NON-REACTIVE). SAMPLE 2: THE ELECSYS CMV IGM RESULT WAS 1.03 COI (REACTIVE). THE ELECSYS CMV IGG RESULT WAS 0.150 U/ML (NON-REACTIVE). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FOR 1 PATIENT ON A COBAS 8000 E 602 MODULE. SAMPLE 1: THE INITIAL CMV IGG RESULT WAS NEGATIVE. THE NUMERIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED IN ANOTHER HOSPITAL USING THE ABBOTT METHOD AND THE CMV IGG RESULT WAS 49.2 U/ML (POSITIVE). ON (B)(6) 2024 THE SAMPLE WAS TESTED USING THE VIDAS BIOMÉRIEUX METHOD AND THE CMV IGG RESULT WAS 10 AU/ML (POSITIVE). ON (B)(6) 2024 THE SAMPLE WAS TESTED AGAIN AND THE ELECSYS CMV IGG RESULT WAS (0.150 U/ML WITH A DATA FLAG) NEGATIVE. THE ELECSYS CMV IGM RESULT WAS 1.0 COI (POSITIVE). THE CMV IGM RESULT USING THE ABBOTT METHOD WAS 4.06 COI (POSITIVE). ON (B)(6) 2024 THE SAMPLE WAS TESTED AGAIN AND THE ELECSYS CMV IGM RESULT WAS 0.998 COI (BORDER). SAMPLE 2: ON (B)(6) 2024 THE CMV IGG RESULT WAS NEGATIVE. THE NUMERIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED IN ANOTHER HOSPITAL USING THE ABBOTT METHOD AND THE CMV IGG RESULT WAS 60.4 U/ML (POSITIVE). ON (B)(6) 2024 THE SAMPLE WAS TESTED USING THE VIDAS BIOMÉRIEUX METHOD AND THE CMV IGG RESULT WAS 10 AU/ML (POSITIVE). THE ELECSYS CMV IGM RESULT WAS 1.0 COI (POSITIVE). THE CMV IGM RESULT USING THE ABBOTT METHOD WAS 3.74 COI (POSITIVE). IT IS UNKNOWN WHICH RESULTS ARE CORRECT.