BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMV IGG ELECSYS E2G

    MDR report key: 20170012 · Received September 9, 2024

    Report

    Report Number
    1823260-2024-02592
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 8, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    07613336198469
    PMA / PMN Number
    K131605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). CALIBRATION SIGNALS FROM THE LAST CALIBRATION ON (B)(6) 2024 WERE WITHIN EXPECTED RANGES. QUALITY CONTROLS RECOVERED WITHIN RANGE ON (B)(6) 2024. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE CMV IGG RESULT MEASURED BY THE CUSTOMER COULD BE REPRODUCED. SINCE THE PATIENT WAS CMV SEROPOSITIVE BEFORE THE LUNG TRANSPLANTATION, A CMV REACTIVATION OR REINFECTION APPEARS PLAUSIBLE DUE TO THE CLEAR CMV IGM REACTIVITY DETECTED IN (B)(6) 2024. IT REMAINS UNCLEAR WHY THE CMV IGG TITER IS NO LONGER DETECTABLE WITH THE ELECSYS CMV IGG ASSAY. DUE TO THE SENSITIVITY AS CLAIMED IN THE PRODUCT LABELING, SINGLE FALSE NEGATIVES CAN OCCUR. A GENERAL PRODUCT PROBLEM WAS NOT FOUND. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTED IN A CMV IGG VALUE OF < 0.150 U/ML WITH A DATA FLAG (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER. SINCE THE PATIENT'S CMV IGG RESULT REMAINED NEGATIVE AND THE CMV IGM RESULT DECREASED, THE CUSTOMER DECIDED TO SEND THE PATIENT SAMPLE TO ANOTHER LABORATORY FOR TESTING USING THE ABBOTT METHOD. THE SAMPLE WAS TESTED USING THE ABBOTT METHOD ON (B)(6) 2024, RESULTING IN A CMV IGG VALUE OF 78.296 AU/ML (REACTIVE). THE SAMPLE WAS ALSO TESTED USING THE ABBOTT METHOD ON (B)(6) 2024, RESULTING IN A CMV IGG VALUE OF 79.520 AU/ML (REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538464 CMV IGG ELECSYS E2G CYTOMEGALOVIRUS IMMUNOASSAY LFZ ROCHE DIAGNOSTICS 77225201 07613336198469

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown MYCOPHENOLATE.| TACROLIMUS.