BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOXO IGM

    MDR report key: 16708386 · Received April 10, 2023

    Report

    Report Number
    1823260-2023-01177
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 13, 2023
    Report Date
    June 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
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. THE RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED. AN EXTENSIVE INVESTIGATION HAS CONFIRMED A LOWER SPECIFICITY FOR REAGENT LOT: 671956 COMPARED TO THE PREVIOUS LOT: 652164, SHOWING AN INCREASE OF APPROXIMATELY 1.2 % IN THE AMOUNT OF REACTIVE ELECSYS TOXO IGM RESULTS. THE DETERMINED SPECIFICITY OF THE AFFECTED LOT: 671956 WAS LOWER COMPARED WITH THE SPECIFICITY CLAIMS IN PRODUCT LABELING, HOWEVER, THE SPECIFICITY WAS WITHIN THE LOWER CONFIDENCE LIMITS OF METHOD COMPARISON STUDIES DOCUMENTED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 0

    NA.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THEY RECEIVED FALSE POSITIVE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS TOXO IGM ON COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER STATED THE NUMBER OF EQUIVOCAL AND POSITIVE PATIENT RESULTS HAS INCREASED SINCE THEY STARTED USING ELECSYS TOXO IGM REAGENT LOT 671956. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. WHEN TESTED USING THE PREVIOUS REAGENT LOT (652164), THE FIRST PATIENT SAMPLE RESULTED IN A TOXO IGM VALUE OF 0.291 COI (NON-REACTIVE). WHEN TESTED TWICE USING NEW REAGENT LOT 671956, THIS SAMPLE RESULTED IN VALUES OF 1.83 COI (REACTIVE) AND 1.86 COI (REACTIVE). WHEN TESTED USING THE PREVIOUS REAGENT LOT (652164), THE SECOND PATIENT SAMPLE RESULTED IN A TOXO IGM VALUE OF 0.28 COI (NON-REACTIVE). WHEN TESTED TWICE USING NEW REAGENT LOT 671956, THIS SAMPLE RESULTED IN VALUES OF 1.99 COI (REACTIVE) AND 2.01 COI (REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753196 ELECSYS TOXO IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS TOXO IGM 67195601 04015630940318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown