BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CMV IGM

    MDR report key: 23288013 · Received October 15, 2025

    Report

    Report Number
    1823260-2025-04184
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 20, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    04015630940189
    PMA / PMN Number
    K142133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE MATERIAL FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE NON-REACTIVE ELECSYS CMV IGM RESULT WAS REPRODUCED. EXTENSIVE ANALYSIS OF THE PATIENT SAMPLE REVEALED THAT THE ELECSYS RESULT WAS SUPPORTED BY OTHER METHODS (PLATELIA CMV IGM AND MIKROGEN RECOMLINE CMV IGM) AND WAS CONSIDERED TO BE CORRECT. THE SCENARIO IS CONSISTENT WITH THE PATIENT IN THE LATE CONVALESCENT PHASE OF A PRIMARY INFECTION, WHICH IS IN ACCORDANCE WITH THE FINDINGS OBTAINED WITH PCR. NO PRODUCT PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 0

    THE E402 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025 WITH NO ISSUES. QC WAS ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    IT WAS CLARIFIED THAT THE UNSPECIFIED ENZYME-LINKED FLUORESCENT ASSAY (ELFA) METHOD WAS THE VIDAS METHOD. SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGM (CMV IGM) ON A COBAS E 402 ANALYTICAL UNIT. THE RESULT FROM THE E402 ANALYZER WAS 0.290 COI (NEGATIVE). THE RESULT FROM AN UNSPECIFIED ENZYME-LINKED FLUORESCENT ASSAY (ELFA) METHOD WAS "BORDERLINE." THE SPECIFIC RESULT WAS NOT PROVIDED. THE DNA BLOOD TEST RESULT WAS "NEGATIVE." THE URINE TEST WAS "POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596152 ELECSYS CMV IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS 86838401 04015630940189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female