BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOXO IGM

    MDR report key: 16487185 · Received March 6, 2023

    Report

    Report Number
    1823260-2023-00678
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 6, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    UDI-DI
    04015630940318
    PMA / PMN Number
    K162678
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE LAST CALIBRATION PERFORMED ON (B)(6)2022, THE SIGNALS WERE LOWER THAN EXPECTED, BUT STILL ACCEPTABLE. QUALITY CONTROL RECOVERY BETWEEN (B)(6)2022 AND (B)(6)2023 WAS ACCEPTABLE. THE CUSTOMER PERFORMED CLEANING MAINTENANCE EVERY 40 DAYS DUE TO THE OPERATOR'S MANUAL RECOMMENDING CLEANING EVERY 10000 CYCLES AND 10000 CYCLES WERE REACHED IN APPROXIMATELY 40 DAYS AT THIS SITE. THE CUSTOMER WAS ADVISED TO CARRY OUT THE CLEANING MAINTENANCE AND AFTER PERFORMING THIS PROCEDURE, NO FURTHER ISSUES WERE OBSERVED. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION BUT WAS NO LONGER AVAILABLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE ELECSYS TOXO IGM IMMUNOASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). AN EXAMPLE WAS PROVIDED FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT TOXO IGM RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED IN A TOXO IGM VALUE OF 1.26 COI (REACTIVE) WHEN TESTED ON THE E 801 ANALYZER ON (B)(6)2023. THE SAMPLE WAS REPEATED ON THE E 801 ANALYZER ON (B)(6)2023, RESULTING IN A VALUE OF 1.23 COI (REACTIVE). THE SAMPLE WAS REPEATED USING AN UNKNOWN TOXO IGM METHOD ON (B)(6)2023, RESULTING IN A VALUE OF 0.13 INDEX (NON-REACTIVE). TOXO IGM REAGENT LOT 65216401 HAS AN EXPIRATION DATE OF JULY 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730794 ELECSYS TOXO IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS TOXO IGM 65216401 04015630940318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown