BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMV IGG ELECSYS E2G

    MDR report key: 19382489 · Received May 23, 2024

    Report

    Report Number
    1823260-2024-01539
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    February 23, 2024
    Report Date
    June 17, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    07613336198469
    PMA / PMN Number
    K131605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6). THE COMPETITOR CMV IGG METHODS USED BY THE CUSTOMER WERE ABBOTT ARCHITECT, VIDAS, AND LIAISON LXL. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CMV IGM RESULTS WERE REACTIVE IN CONCORDANCE WITH RESULTS FROM ABBOTT AND DIASORIN, CLEARLY DETECTING THE PRIMARY INFECTION. THE PROVIDED RESULTS OBTAINED WITH SEVERAL METHODS PROVIDE A CLEAR PICTURE OF A YET INCOMPLETE SEROCONVERSION. AN INFLUENCE OF THE DRUG VALACICLOVIR ON THE CMV IGG ASSAY CAN BE RULED OUT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. RESULTS FROM FOUR OF THE PATIENT'S SAMPLES DID NOT AGREE WITH RESULTS MEASURED WITH COMPETITOR ASSAYS. RESULTS FOR THE ELECSYS CMV IGG ASSAY BECAME NEGATIVE OVER TIME, BUT NOT RESULTS MEASURED WITH COMPETITOR SYSTEMS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE RESULTS HIGHLIGHTED IN YELLOW ARE QUESTIONABLE. THE UNITS OF MEASURE USED FOR THE COMPETITOR ASSAYS WERE REQUESTED, BUT NOT PROVIDED. ALL SAMPLES WERE TESTED USING ELECSYS CMV IGG REAGENT LOT NUMBER 743344 (EXPIRATION DATE UNKNOWN) EXCEPT FOR SAMPLE 8, WHICH WAS TESTED USING LOT 772252 (EXPIRATION DATE = 31-JAN-2025).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583357 CMV IGG ELECSYS E2G CYTOMEGALOVIRUS IMMUNOASSAY LFZ ROCHE DIAGNOSTICS 743344, 77225201 07613336198469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female VALACICLOVIR.