BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS

    MDR report key: 7855712 · Received September 7, 2018

    Report

    Report Number
    1823260-2018-03029
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    March 7, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    04015630923489
    PMA / PMN Number
    K131605
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES FROM BOTH PATIENTS WERE SUBMITTED FOR INVESTIGATION WHERE THE SAMPLES WERE REACTIVE WHEN TESTED ON THE RECOMLINE CMV IGM AND THE RECOMLINE CMV IGG ASSAY. ALL SAMPLES FROM THE PATIENTS SHOWED ELEVATED IGG SIGNALS SUPPORTING THE SUSPICION OF A PRIMARY CMV INFECTION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. PRODUCT LABELING STATES FALSE NEGATIVE RESULTS MAY OCCUR FOR CMV IGG. THE INVESTIGATION DETERMINED THE CMV IGG ASSAY PERFORMS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS CMV IGG ASSAY (CMV IGG) AND ELECSYS CMV IGM IMMUNOASSAY (CMV IGM) ON A COBAS 6000 C (501) MODULE COMPARED TO OTHER METHODS. BASED ON THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT WERE DISCREPANT FOR CMV IGG AND CMV IGM AND THE RESULTS FOR 1 PATIENT WERE DISCREPANT FOR CMV IGG. THIS MEDWATCH WILL COVER CMV IGG. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CMV IGM RESULTS. THE INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C501 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696791 CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA ASKU 04015630923489

    Patients

    Seq Age Sex Outcome Treatment
    1