BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 TOTAL T3

    MDR report key: 6081499 · Received November 7, 2016

    Report

    Report Number
    2432235-2016-00678
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    September 19, 2016
    Report Date
    June 29, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CDP
    PMA / PMN Number
    K905214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSELY LOW TOTAL T3 RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00678 WAS FILED ON NOVEMBER 7, 2016. ADDITIONAL INFORMATION (06/09/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST COULD NOT REVIEW THE LEVEL SENSE MECHANISM OF THE INSTRUMENT AS SPY FILES WERE NOT AVAILABLE FOR REVIEW. THE HSC SPECIALIST VERIFIED THAT THE AFFECTED SAMPLES WERE RUN USING KIT LOT 339. THE SAMPLES WERE TESTED WITHOUT ANY ISSUE WITH THE NEWLY INSTALLED KIT LOT 341. KIT LOT 339 EXPIRED ON MAY 31, 2017. THE CAUSE OF THE DISCORDANT, FALSELY LOW T3 RESULTS ON PATIENT SAMPLES IS UNKNOWN. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW TOTAL TRIIODOTHYRONINE (TOTAL T3) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 339. THE SAMPLES WERE REPEATED ON ANOTHER IMMULITE INSTRUMENT, ALSO RESULTING LOW. THE CUSTOMER RAN SAMPLE IDS 850813, 850947 AND 722745 ON AN ADVIA CENTAUR XP INSTRUMENT AND THE RESULTS WERE HIGHER. THE CUSTOMER ALSO RAN ALL THE SAMPLES USING A NEW KIT LOT 341 AND THE RESULTS WERE NORMAL AND ACCEPTABLE TO THE CUSTOMER. IT IS UNKNOWN IF THE DISCORDANT OR THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW TOTAL T3 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734986 IMMULITE 2000 TOTAL T3 IMMULITE 2000 TOTAL T3 CDP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 TOTAL T3 339

    Patients

    Seq Age Sex Outcome Treatment
    1