ELECSYS CMV IGM

Additional Manufacturer Narrative

ON (B)(6) 2025, SPECIFIC RESULTS WERE PROVIDED FOR 3 SEPARATE SAMPLES FROM THE PATIENT. ON (B)(6) 2025, THE CMV IGM RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED ON A VIDAS ANALYZER AND THE CMV IGM RESULT WAS POSITIVE. ON (B)(6) 2025, THE CMV IGM RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED ON A VIDAS ANALYZER AND THE CMV IGM RESULT WAS POSITIVE. A THIRD SAMPLE WAS COLLECTED 3 WEEKS LATER AND THE CMV IGM RESULT WAS NEGATIVE. THE INVESTIGATION DETERMINED THAT THE RESULTS PROVIDED ARE INDICATIVE OF AN EARLY CMV INFECTION. INDIVIDUALS AT THE EARLY STAGE OF ACUTE INFECTION MAY NOT EXHIBIT DETECTABLE AMOUNTS OF CMV IGM ANTIBODIES. IN SOME INDIVIDUALS, A BORDERLINE OR LOW POSITIVE RESULT WITH THE ELECSYS CMV IGG ASSAY MAY BE FOUND AND INDICATE AN EARLY ACUTE INFECTION. A SECOND SAMPLE SHOULD BE TESTED WITHIN 2-3 WEEKS. THE DETECTION OF CMV IGM AND/OR A SIGNIFICANT INCREASE OF THE ELECSYS CMV IGG ANTIBODY TITER IN THE SECOND SAMPLE SUPPORTS THE DIAGNOSIS OF AN ACUTE CMV INFECTION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ELECSYS CMV IGM ASSAY PERFORMS WITHIN SPECIFICATION.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FOR 1 PATIENT SAMPLE ON AN UNKNOWN COBAS ANALYZER COMPARED TO A COMPETITOR ANALYZER. THE ROCHE RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED ON A VIDAS ANALYZER AND THE RESULT WAS POSITIVE.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.