BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CMV IGG

    MDR report key: 14694060 · Received June 15, 2022

    Report

    Report Number
    1823260-2022-01738
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 18, 2022
    Report Date
    August 19, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    04015630940172
    PMA / PMN Number
    K131605
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION AND THE RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED.

    Additional Manufacturer Narrative · 0

    FOR CALIBRATIONS PERFORMED ON (B)(6)2022 AND (B)(6)2022, SIGNALS WERE WITHIN EXPECTED RANGES. ON (B)(6)2022, CONTROLS RECOVERED WITHIN SPECIFIED RANGES. FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE DETERMINED IT TO BE CORRECTLY NON-REACTIVE WITH THE ELECSYS CMV IGG ASSAY. THE NON-REACTIVE ELECSYS CMV IGG RESULT WAS SUPPORTED BY MIKROGEN RECOMLINE BLOT RESULTS, WHICH WERE NEGATIVE FOR CMV IGG AND REACTIVE FOR CMV IGM. FURTHER INVESTIGATION INDICATED THAT A PRIMARY INFECTION WAS UNLIKELY DUE TO THE CONSTANT IGM RESPONSE AND THE ABSENCE OF A SEROCONVERSION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGG ASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). THE SAMPLE RESULTED IN A CMV IGG VALUE OF 0.31 U/ML (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER. THE VALUE FROM THE E 801 ANALYZER WAS REPORTED OUTSIDE OF THE LABORATORY. AN ALIQUOT OF THIS SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING THE DIASORIN LIAISON XL METHOD, RESULTING IN A VALUE OF 104 U/ML (IMMUNE/REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807526 ELECSYS CMV IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA 59618801 04015630940172

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female