BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOXO IGM

    MDR report key: 18194723 · Received November 22, 2023

    Report

    Report Number
    1823260-2023-03754
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 26, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    UDI-DI
    04015630921485
    PMA / PMN Number
    K162678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE REAGENT PERFORMED WITHIN SPECIFICATIONS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A SAMPLE FROM THE PATIENT WAS NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(6). THE SERIAL NUMBER OF THE UNKNOWN ROCHE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGM ON A COBAS E411 RACK AND A SECOND UNKNOWN ROCHE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 1.24 COI (REACTIVE) WHEN TESTED ON THE E411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS REPEATED ON A SECOND UNKNOWN ROCHE ANALYZER ON (B)(6) 2023, RESULTING IN A TOXO IGM VALUE OF 1.25 COI (REACTIVE). THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND TESTED USING AN UNKNOWN METHOD, RESULTING IN A TOXO IGM VALUE OF 0.07 UI/ML (NEGATIVE). THE SAMPLE WAS ALSO SENT TO A SECOND REFERENCE LABORATORY WHERE IT WAS TESTED USING AN UNKNOWN METHOD, RESULTING IN A TOXO IGM VALUE OF 0.06 INDEX (NON-REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989329 ELECSYS TOXO IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS 71292901 04015630921485

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown