BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TSHR

    MDR report key: 13024993 · Received December 17, 2021

    Report

    Report Number
    1823260-2021-03761
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    January 18, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    07613336160305
    PMA / PMN Number
    K193313
    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

    THE CUSTOMER CLARIFIED THAT THE FOLLOWING DATA REPLACES THE ONE EXAMPLE PROVIDED IN THE INITIAL MEDWATCH: TWO EXAMPLES OF PATIENT DATA WERE PROVIDED. NO INCORRECT RESULTS FROM THESE SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 4.16 IU/ML WHEN TESTED ON THE (B)(6) ANALYZER. WHEN THIS SAMPLE WAS TESTED ON THE (B)(6) ANALYZER, THE RESULT WAS < 0.800 IU/ML ACCOMPANIED BY A DATA FLAG. THE SECOND SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 4.67 IU/ML WHEN TESTED ON THE (B)(6)ANALYZER. WHEN THIS SAMPLE WAS TESTED ON THE (B)(6) ANALYZER, THE RESULT WAS < 0.800 IU/ML ACCOMPANIED BY A DATA FLAG.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DETERMINED "THE DATA RECEIVED FROM THE COBAS E 601 AS INCORRECT AND DUE TO REAGENT PREPARATION AND CALIBRATION PROBLEMS." THE INVESTIGATION REVIEWED THE CALIBRATION RESULTS FROM THE E 601 MODULE AND FOUND HIGH RESULTS FOR CALIBRATION MATERIAL #1 AND ACCEPTABLE RESULTS FOR CALIBRATION MATERIAL #2. THE INVESTIGATION CONFIRMED NO QC MATERIAL WAS MEASURED ON THE DATE OF THE EVENT. PER PRODUCT LABELING, "CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION. THE CONTROL INTERVALS AND LIMITS SHOULD BE ADAPTED TO EACH LABORATORY¿S INDIVIDUAL REQUIREMENTS. VALUES OBTAINED SHOULD FALL WITHIN THE DEFINED LIMITS. EACH LABORATORY SHOULD ESTABLISH CORRECTIVE MEASURES TO BE TAKEN IF VALUES FALL OUTSIDE THE DEFINED LIMITS." BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH AN UNKNOWN REAGENT HANDLING ISSUE. UPDATED MEDWATCH FIELD B3 - DATE OF EVENT

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR 10 PATIENTS TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER AND A COBAS 6000 E 601 MODULE. THE INITIAL ANTI-TSHR RESULTS FROM THE E 601 MODULE WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING ON THE E 411 ANALYZER. THE CUSTOMER PROVIDED ONE EXAMPLE OF QUESTIONABLE ANTI-TSHR RESULTS: THE PATIENT'S ANTI-TSHR RESULT ON THE E 601 MODULE WAS 35 IU/ML. THE PATIENT'S ANTI-TSHR RESULT ON THE E 411 ANALYZER WAS 1.3 IU/ML. THE E 601 MODULE AND THE E 411 ANALYZER HAD THE SAME ANTI-TSHR REAGENT. THE ANTI-TSHR REAGENT LOT NUMBER WAS 55219602 WITH AN EXPIRATION DATE OF 31-AUG-2022. THE E 601 MODULE SERIAL NUMBER WAS (B)(4). THE E 411 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931968 ELECSYS ANTI-TSHR THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM JZO ROCHE DIAGNOSTICS NA 55219602 07613336160305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown