BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CMV IGM

    MDR report key: 20129424 · Received September 3, 2024

    Report

    Report Number
    1823260-2024-02542
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    04015630940189
    PMA / PMN Number
    K163569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE PROVIDED PATIENT SAMPLE MATERIAL FOUND THE CUSTOMER'S NON-REACTIVE ELECSYS CMV IGM RESULTS WERE REPRODUCIBLE. THE NON-REACTIVE ELECSYS CMV IGM RESULT WAS CONFIRMED BY THE RECOMLINE CMV IGM BLOT (MIKROGEN). THE INVESTIGATION DETERMINED THE SAMPLE WAS CONSISTENT WITH AN ACUTE PRIMARY CMV INFECTION (2-3 MONTHS AGO) DUE TO THE DETECTION OF LOW IGG TITERS WITH A LOW CMV IGG AVIDITY AND A DECLINING CMV IGM REACTIVITY BELOW THE BORDERLINE RANGE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL FROM THE PATENT WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FROM THE COBAS E 801 MODULE. THE ROCHE IGM RESULT WAS 0.3 (NEGATIVE) REPEATEDLY. THE BIOMERIEUX IGM RESULT WAS 1.72 (POSITIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735203 ELECSYS CMV IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS 764032 04015630940189

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female