BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOXO IGM

    MDR report key: 20090532 · Received August 28, 2024

    Report

    Report Number
    1823260-2024-02493
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 3, 2024
    Report Date
    October 28, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    UDI-DI
    04015630921485
    PMA / PMN Number
    K162678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TOXO IGM REAGENT THAT WAS USED ON 03-AUG-2024 WAS EXPIRED AND ITS LOT NUMBER WAS 740654. THE TOXO IGM REAGENT LOT NUMBER USED ON 07-AUG-2024 WAS 780868. THE EXPIRATION DATE WAS 31-JAN-2025. THE COBAS E411 SERIAL NUMBER WAS (B)(6). ON (B)(6) 2024 THE 1ST CALIBRATION OF LOT 780868 WAS PERFORMED AND THE CALIBRATION SIGNALS WERE WITHIN EXPECTED RANGES. ON (B)(6) 2024 THE QC WAS PERFORMED WITH THE EXPIRED LOT REAGENT. ON (B)(6) 2024 THE QC WAS PERFORMED AND IT WAS WITHIN THE ASSIGNED RANGES. THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 28-AUG-2024. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED ADDITIONAL INFORMATION ABOUT THE PATIENT: THE PATIENT WAS REPORTEDLY ALLEGED TO BE MEDICALLY TREATED BASED ON THE REACTIVE ELECSYS TOXO IGM RESULT AND IT WAS REPORTEDLY ALLEGED THAT SHE SHOWED SIDE EFFECTS (NAUSEA AND VOMITING) TO THE ADMINISTERED MEDICATION. THE PHYSICAL INVESTIGATION OF THE SAMPLE SHOWED THAT IT WAS THAWED BUT SLIGHTLY COOLED. DURING THE INVESTIGATION, THE SAMPLE WAS TESTED USING THE FOLLOWING: ELECSYS TOXO IGM AND THE RESULT WAS 1.84 COI AND INTERPRETED AS REACTIVE. ANALYSIS WITH AN INTERFERENCE-REDUCING SUBSTANCE: THE REACTIVITY WAS ASSESSED AS BASED ON INTERFERING ANTIBODIES (IGM-CLASS) DIRECTED AGAINST THE SPATIAL STRUCTURE OF THE STANDARD RUTHENIUM LABEL. BIORAD PLATELIA TOXO IGM AND THE RESULT WAS NEGATIVE. ELECSYS TOXO IGG AND THE RESULT WAS <0.130 IU/ML AND INTERPRETED AS NON-REACTIVE. THE REACTIVITY OBSERVED FOR THE SAMPLE WITH ELECSYS TOXO IGM WAS BASED ON THE INTERFERING ANTIBODIES AGAINST THE ELECSYS STANDARD RUTHENIUM LABEL IN THE PATIENT SAMPLE. THE SAMPLE WAS NON-REACTIVE FOR ELECSYS TOXO IGG. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM) WHEN COPMAPRED TO A COMPETITOR'S ANALYZER (ABBOTT) AT ANOTHER FACILITY. INITIAL RESULT: 1.60 COI AND INTERPRETED AS REACTIVE. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY TO BE REPEATED USING AN ABBOTT INSTRUMENT AND THE 1ST REPEAT RESULT WAS NEGATIVE. ON (B)(6) 2024 THE CUSTOMER REPEATED THE SAMPLE AND THE 2ND REPEAT RESULT WAS 1.68 COI AND INTERPRETED AS REACTIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT AND THE PHYSICIAN CONSIDERED THE NEGATIVE RESULT TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198770 ELECSYS TOXO IGM ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS 740654, 780868 04015630921485

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female