BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TPO

    MDR report key: 14205678 · Received April 26, 2022

    Report

    Report Number
    1823260-2022-01176
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 29, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    04015630939626
    PMA / PMN Number
    K051890
    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

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION WAS ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL RESULTS FOR PATIENT 1 WERE PROVIDED: ON (B)(6) 2022 THE GAMGT RESULT WAS 31. ON (B)(6) 2022 THE CPK RESULT WAS 69. ON (B)(6) 2022 THE FSHTE RESULT WAS 0.3. ON (B)(6) 2022 THE LHTE RESULT WAS 0.3. ON (B)(6) 2022 THE AATIR RESULT WAS 15. ON (B)(6) 2022 THE AATPOTE RESULT WAS 34. ON (B)(6) 2022 THE PRLTE RESULT WAS 7. THE UNITS OF MEASURE FOR THE ADDITIONAL RESULTS WERE NOT PROVIDED. THE DAILY ALARM TRACE CONTAINED 3 SAMPLE CLOT ALARMS. THE CUSTOMER PERFORMED A LIQUID FLOW CLEAN MAINTENANCE BEFORE (B)(6) 2022) AND AFTER (B)(6)2022) THE EVENT.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO RESULTS FOR 3 PATIENTS ON A COBAS E 801 ANALYTICAL UNIT, SERIAL NUMBER (B)(4). PATIENT 1: THE INITIAL RESULT WAS 80.1 IU/ML (PRIMARY TUBE). ON (B)(6) 2022, THE REPEATED RESULT WAS 15.0 IU/ML (FROM THE SAME PRIMARY TUBE). PATIENT 2: ON (B)(6) 2022, THE INITIAL RESULT WAS 70.1 IU/ML (PRIMARY TUBE). ON (B)(6) 2022, THE REPEATED RESULT WAS 9 IU/ML (FROM THE SAME PRIMARY TUBE). PATIENT 3: ON (B)(6) 2022, THE INITIAL RESULT WAS 66 IU/ML. ON (B)(6) 2022, THE REPEATED RESULT WAS <34 IU/ML. THE REPEATED RESULTS WERE PERFORMED ON ANOTHER E801 MODULE. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774780 ELECSYS ANTI-TPO SYSTEM, TEST, THYROID AUTOANTIBODY JZO ROCHE DIAGNOSTICS NA 590342 04015630939626

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male