BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TPO

    MDR report key: 19840644 · Received July 26, 2024

    Report

    Report Number
    1823260-2024-02177
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 12, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    04015630929702
    PMA / PMN Number
    K051890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANTI-TPO REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION D4 WAS UPDATED. THE CALIBRATION WAS NOT PERFORMED DAILY AS RECOMMENDED. THE PRODUCT LABELING STATES: "RENEWED CALIBRATION ON ALL ANALYZERS: DAILY: WHEN USING THE SAME REAGENT KIT ON THE ANALYZERS." THE PROVIDED QC SCREENSHOT SHOWED THAT THE QC WAS WITHIN RANGES, BUT THE MEASUREMENT DATE/TIME AND THE ACTUAL NUMERIC RESULTS WERE NOT SHOWN. THE PROVIDED PRE-ANALYTICAL SHOWED THAT THE CUSTOMER USED 13 MM DIAMETER TUBES BUT DID NOT USE THE REQUIRED RACK ADAPTERS FOR THEM. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS ANTI-TPO ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: >600.0 IU/ML (ACCOMPANIED BY A DATA FLAG AND CONSIDERED ABOVE THE MEASURING RANGE). THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS THEN REPEATED. 1ST REPEAT RESULT: 10.22 IU/ML OBTAINED WITH A MANUAL DILUTION OF 1:5 AND, THEREFORE, MULTIPLIED BY THE FACTOR 5 THE FINAL RESULT WOULD BE 51.1 IU/ML. 2ND REPEAT RESULT: 18.76 IU/ML (NO DILUTION). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE 2ND REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529779 ELECSYS ANTI-TPO SYSTEM, TEST, THYROID AUTOANTIBODY JZO ROCHE DIAGNOSTICS 769146 04015630929702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown