BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOXO IGM

    MDR report key: 21872034 · Received April 21, 2025

    Report

    Report Number
    1823260-2025-01193
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    December 19, 2023
    Report Date
    April 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    UDI-DI
    04015630940318
    PMA / PMN Number
    K162678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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). THE LAST CALIBRATION WAS PERFORMED ON 16-NOV-2023. CONTROLS RUN ON THE DAY OF THE EVENT WERE WITHIN RANGE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE PATIENT HAD A NON-REACTIVE TOXO IGG VALUE (0.18 COI). SAMPLES THAT HAVE INDETERMINATE OR LOW REACTIVE RESULTS FOR TOXO IGM AND AT THE SAME TIME NON-REACTIVE FOR TOXO IGG SHOULD BE CONSIDERED FOR A FOLLOW-UP ANALYSIS WITHIN 2-3 WEEKS OR FOR A RE-RUN WITH ANOTHER ASSAY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THEY RECEIVED A QUESTIONABLE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGM ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT SAMPLE ALLEGEDLY RESULTED IN A TOXO IGM VALUE OF 1.31 COI (POSITIVE) WHEN TESTED ON THE E 801 ANALYZER. THE PATIENT WAS THEN TESTED AT ANOTHER LABORATORY USING AN UNKNOWN METHOD AND THE TOXO IGM VALUE FROM THE OTHER LABORATORY WAS ALLEGEDLY NEGATIVE. A SPECIFIC RESULT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517293 ELECSYS TOXO IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS 712936 04015630940318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female