BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 22770546 · Received August 11, 2025

    Report

    Report Number
    1823260-2025-02434
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GENERAL REAGENT ISSUE WAS EXCLUDED. IT WAS NOTED THAT THE SERVICE VISIT WAS CANCELLED DUE TO THE ISSUE BEING RESOLVED WITHOUT ACTION. THE INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 861168. THE EXPIRATION DATE IS MAY 2026. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS C 303 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS 16 MG/DL, AND THE REPEATED RESULT WAS 9 MG/DL. SAMPLE 2: THE INITIAL RESULT WAS 4.01 MG/DL, AND THE REPEATED RESULT WAS 9.31 MG/DL. SAMPLE 3: THE INITIAL RESULT WAS 7.63 MG/DL, AND THE REPEATED RESULT WAS 8.95 MG/DL. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160787 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown