BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 CYTOMEGALOVIRUS IGG

    MDR report key: 4190548 · Received October 21, 2014

    Report

    Report Number
    2432235-2014-00608
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LFZ
    PMA / PMN Number
    K993952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE POSITIVE CYTOMEGALOVIRUS IGG RESULT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # 2432235-2014-00608 WAS FILED ON OCTOBER 21, 2014.ADDITIONAL INFORMATION (12/12/2014): THE REGIONAL SUPPORT CENTER SPECIALIST SPOKE TO THE CUSTOMER. THE CUSTOMER DOES NOT HAVE SAMPLES FROM THE PATIENT AVAILABLE FOR TESTING. THE CAUSE OF THE DISCORDANT CYTOMEGALOVIRUS IGG RESULTS ON SAMPLES FROM ONE PATIENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE POSITIVE RESULTS ON ONE PATIENT SAMPLE FOR THE CYTOMEGALOVIRUS IGG (CMV IGG) ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT USING REAGENT LOT 295. THE SAME SAMPLE WAS REPEATED WHICH ALSO RESULTED AS POSITIVE. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND TESTED ON AN IMMULITE INSTRUMENT, WHICH AGAIN RESULTED AS POSITIVE. THE FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE NEW SAMPLE WAS TESTED ON AN ALTERNATE PLATFORM USING ELISA AND THE RESULT WAS NEGATIVE FOR CMV IGG. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE RESULT ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667246 IMMULITE 2000 CYTOMEGALOVIRUS IGG IMMULITE 2000 CYTOMEGALOVIRUS IGG LFZ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 CYTOMEGALOVIRUS IGG 295

    Patients

    Seq Age Sex Outcome Treatment
    1