BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

    MDR report key: 12076065 · Received June 28, 2021

    Report

    Report Number
    1823260-2021-01846
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 7, 2021
    Report Date
    February 28, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K051890
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATIONS HAVE DETERMINED THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC HANDLING.

    Additional Manufacturer Narrative · 0

    UPON ANALYSIS OF DATA FILES FROM THE AFFECTED ANALYZERS, IT WAS DETERMINED THAT OVERALL PERFORMANCE OF THE ANALYZERS AND ASSAYS WERE VERY GOOD. DATA ANALYSIS REVEALED THE ISSUE TO BE CONSISTENT WITH POOR SAMPLE QUALITY. IT WAS ALSO DETERMINED THAT THE SAMPLE CONTAINERS USED BY THE CUSTOMER HAVE AN OUTER DIAMETER OF 12.5 MM.. THE TUBE WALLS ARE ALSO RELATIVELY THICK AND THEY HAVE A CONICAL BOTTOM. PER PRODUCT LABELING, THE MINIMUM REQUIRED TUBE DIAMETER FOR THE E 801 ANALYZER IS 13 MM.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER PERFORMED MULTIPLE ACTIONS ON THE INVOLVED ANALYZERS, INCLUDING PARTS REPLACEMENTS, CLEANING PROCEDURES, ADJUSTMENTS, AND PERFORMANCE TESTING. THE ISSUE STILL OCCURS AND TROUBLESHOOTING IS ONGOING. THIS EVENT OCCURRED IN (B)(6). UDI NUMBER = (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLE TESTED WITH ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON MULTIPLE COBAS 8000 E 801 MODULE ANALYZERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THE FIRST SAMPLE. IT IS UNKNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THE SECOND AND THIRD SAMPLES. AT THE TIME THE EVENT STARTED, THE CUSTOMER WAS USING ANTI-TPO REAGENT LOT NUMBER 52267901, WITH AN EXPIRATION DATE OF 31-JUL-2021. THE FIRST SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 48 IU/ML AND REPEATED AS 15 IU/ML ON E 801 ANALYZER SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE SECOND SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 55 IU/ML AND REPEATED WITH VALUES OF 12 IU/ML AND 12 IU/ML. THE E 801 ANALYZER SERIAL NUMBER USED FOR TESTING OF THIS SAMPLE WAS EITHER SERIAL NUMBER (B)(4) OR SERIAL NUMBER (B)(4). THE SPECIFIC ANALYZER SERIAL NUMBER USED FOR TESTING IS NOT KNOWN. AS OF (B)(6) 2021, THE CUSTOMER STARTED USING ANTI-TPO REAGENT LOT NUMBER 538863. THE EXPIRATION DATE FOR THIS LOT NUMBER WAS REQUESTED, BUT NOT PROVIDED. ON (B)(6) 2021, THE THIRD SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 37 IU/ML WHEN TESTED ON E 801 SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED TWICE USING E 801 ANALYZER SERIAL NUMBER (B)(4) ON (B)(6) 2021, RESULTING IN VALUES OF 10 IU/ML AND 11 IU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970764 ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO SYSTEM, TEST, THYROID AUTOANTIBODY JZO ROCHE DIAGNOSTICS NA 52267901, 538863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown