BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 703 ANALYTICAL UNIT

    MDR report key: 24944524 · Received April 21, 2026

    Report

    Report Number
    1823260-2026-01531
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 29, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336200544
    PMA / PMN Number
    K253490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUCOSE HK GEN.3 REAGENT LOT NUMBER IS 919276 OR 926184. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THAT THE TUBES IN THE RINSE STATION NEEDED TO BE REPLACED. HE REPLACED THE TUBES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 8 PATIENTS' SAMPLES TESTED WITH THE GLUCOSE HK GEN.3 ASSAY ON A COBAS C 703 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 22 MG/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. REPEAT RESULT: 179 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. SAMPLE 2: INITIAL RESULT: 24 MG/DL. REPEAT RESULT: 86 MG/DL. SAMPLE 3: INITIAL RESULT: 29 MG/DL. REPEAT RESULT: 97 MG/DL. SAMPLE 4: INITIAL RESULT: 24 MG/DL. REPEAT RESULT: 92 MG/DL. SAMPLE 5: INITIAL RESULT: <2 MG/DL. 1ST REPEAT RESULT: 24 MG/DL. 2ND REPEAT RESULT: 112 MG/DL. SAMPLE 6: INITIAL RESULT: 19 MG/DL. REPEAT RESULT: 80 MG/DL. SAMPLE 7: INITIAL RESULT: 28 MG/DL. REPEAT RESULT: 119 MG/DL. SAMPLE 8: INITIAL RESULT: 21 MG/DL. REPEAT RESULT: 89 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322800 COBAS C 703 ANALYTICAL UNIT ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ROCHE DIAGNOSTICS C703 07613336200544

    Patients

    Seq Age Sex Outcome Treatment
    1