BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CALCITONIN

    MDR report key: 24689964 · Received March 25, 2026

    Report

    Report Number
    1823260-2026-01087
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKR
    PMA / PMN Number
    K132828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE SAMPLE HAS BEEN REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CALCITONIN RESULT FROM THE COBAS E 402 ANALYTICAL UNIT FOR ONE PATIENT. THE PATIENT'S FIRST RESULT WITH THE COBAS E 402 WAS 1.3 NG/L. THE RESULT WITH THE DIASORIN LIAISON XL WAS 50.3 NG/L. THE PATIENT'S RESULT 4 MONTHS LATER ON THE COBAS E 402 WAS 0.9 NG/L. THE RESULT WITH THE DIASORIN LIAISON XL WAS 28.6 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747109 ELECSYS CALCITONIN CALCITONIN TEST SYSTEM JKR ROCHE DIAGNOSTICS 83695701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BISOPROLOL| COVERSYL| CRESTOR| TRADONAL