BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOSE HK GEN.3

    MDR report key: 23810856 · Received December 15, 2025

    Report

    Report Number
    1823260-2025-05126
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 26, 2025
    Report Date
    June 8, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    UDI-DI
    07613336121283
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT USING PLASMA COLLECTED IN LITHIUM HEPARIN (LI-HEP) WAS 137 MG/DL. RERUN RESULT USING PLASMA COLLECTED IN SODIUM FLUORIDE (NAF) WAS 77.9 MG/DL. SAMPLE 2: THE INITIAL RESULT USING PLASMA COLLECTED IN LI-HEP 90.4 MG/DL. THE REPEAT RESULT USING PLASMA COLLECTED IN NAF WAS 71.5 MG/DL. (B)(6) 2025, THE SAMPLE COLLECTED IN LI-HEP WAS REPEATED AND THE RESULT WAS 57.8 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290283 GLUCOSE HK GEN.3 GLUCOSE HEXOKINASE CFR ROCHE DIAGNOSTICS 88912 07613336121283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown