BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOXO IGM

    MDR report key: 14735009 · Received June 17, 2022

    Report

    Report Number
    1823260-2022-01769
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 23, 2022
    Report Date
    August 12, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    UDI-DI
    04015630921485
    PMA / PMN Number
    K162678
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: NA.

    Additional Manufacturer Narrative · 0

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION AND THE RESULT OBTAINED BY THE CUSTOMER COULD BE REPRODUCED. IT WAS DETERMINED THE SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST THE RUTHENIUM COMPONENT OF THE ELECSYS TOXO IGM IMMUNOASSAY. THE SAMPLE IS NON-REACTIVE FOR TOXO IGG. PER PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO IMMUNOLOGICAL COMPONENTS, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." BASED ON THE SPECIFICITY CLAIM FOR THE ELECSYS TOXO IGM IMMUNOASSAY, SINGLE FALSE POSITIVES CAN OCCUR.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TOXO IGM IMMUNOASSAY ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 2.55 COI (REACTIVE) WHEN TESTED ON THE E 601 ANALYZER. THE SAMPLE WAS REPEATED USING THE BIOMERIUEX METHOD AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED ON THE E 601 ANALYZER ON (B)(6) 2022, RESULTING IN ONLY A DATA FLAG INDICATING SYSTEM REAGENT VOLUME WAS SHORT. THE SAMPLE WAS REPEATED AGAIN ON THE E 601 ANALYZER ON (B)(6) 2022, RESULTING IN A VALUE OF 2.52 COI (REACTIVE). ON (B)(6) 2022, THE SAMPLE WAS TESTED WITH AN UNKNOWN COMPETITOR CHEMILUMINESCENCE ASSAY, RESULTING IN A NEGATIVE TOXO IGM VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398899 ELECSYS TOXO IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS TOXO IGM 59034001 04015630921485

    Patients

    Seq Age Sex Outcome Treatment
    1 Female