BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CMV IGM

    MDR report key: 19807365 · Received July 23, 2024

    Report

    Report Number
    1823260-2024-02120
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    04015630940189
    PMA / PMN Number
    K163569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS A. PATIENT INFORMATION, B6 RELEVANT TESTS/LABORATORY DATA, AND B7 OTHER RELEVANT HISTORY UPDATED. ON (B)(6) 2024, THE CUSTOMER REPORTED THAT A NEW SAMPLE FROM PATIENT 1 ALSO GAVE DISCREPANT ELECSYS CMV IGM RESULTS: ON (B)(6) 2023: THE RESULT FROM THE COBAS E 801 ANALYTICAL UNIT WAS "NEGATIVE". THE RESULT FROM THE VIDAS ANALYZER WAS 1.09 CUT-OFF INDEX COI (POSITIVE). ON (B)(6) 2024, THE CUSTOMER REPORTED DISCREPANT ELECSYS CMV IGM RESULTS FROM A DIFFERENT PATIENT (PATIENT 2): ON (B)(6) 2023: THE RESULT FROM THE COBAS E 801 ANALYTICAL UNIT WAS "NEGATIVE". THE RESULT FROM THE VIDAS ANALYZER WAS 0.87 COI (POSITIVE). INVESTIGATION RESULTS: PATIENT 1: THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION AND WAS TESTED WITH THE FOLLOWING: ELECSYS CMV IGM AND CMV IGG - THE CUSTOMER'S RESULTS WERE CONFIRMED. CMV IGG AVIDITY TEST - A HIGHER RESULT WAS OBTAINED (INVESTIGATION'S RESULT INTERPRETATION: GRAY ZONE; CUSTOMER'S RESULT INTERPRETATION: LOW AVIDITY). CMV IGG BLOT - BROAD ANTIGEN REACTIVITY WAS DETECTED WITH EARLY AND LATE PHASE ANTIGENS, WHICH INDICATES CMV INFECTION OF >12 WEEKS AGO. ELECSYS CMV IGG AVIDITY ASSAY - A SLIGHTLY INCREASING CMV IGG AVIDITY WAS DETECTED. THE INVESTIGATION DETERMINED THAT THE RESULTS INDICATE A PRIMARY INFECTION IN THE LATE ACUTE INFECTION PHASE BASED ON THE PRESENCE OF INCREASING IGG TITERS, AN INCREASING CMV IGG AVIDITY, AND A DECLINING CMV IGM REACTIVITY; A SECONDARY CMV INFECTION OR A CMV REACTIVATION CANNOT BE COMPLETELY RULED OUT. PATIENT 2: THE INVESTIGATION DETERMINED THAT THE PATIENT'S RESULTS INDICATE A LATE-STAGE CMV INFECTION. PRODUCT LABELING STATES "HOW DOES THE CMV IGM ASSAY PERFORM AND WHAT ARE ITS KEY FEATURES? IN SUMMARY, THE TEST IS DESIGNED TO DETECT ACUTE INFECTIONS WHERE CONGENITAL RISK LIES." THE INVESTIGATION REVIEWED THE HANDLING AND PROCESSING OF PATIENT 1'S SAMPLE; NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE CALIBRATION AND QC DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGM RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE PATIENT WAS EXPECTED TO BE CMV IGM POSITIVE BASED ON THE PREVIOUS RESULT FROM ANOTHER LABORATORY THAT USES A VIDAS ANALYZER ( ON (B)(6) 2024: 1.25 AU/ML - POSITIVE). ON (B)(6) 2024: THE RESULT FROM THE ANALYZER WAS 0.571 CUT-OFF INDEX COI (NEGATIVE/NON-REACTIVE). THE RESULT FROM THE VIDAS ANALYZER WAS 1.23 COI (POSITIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936049 ELECSYS CMV IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS 76403201 04015630940189

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female