BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 703 ANALYTICAL UNIT

    MDR report key: 25152711 · Received May 12, 2026

    Report

    Report Number
    1823260-2026-01872
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336200544
    PMA / PMN Number
    K253490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHOLESTEROL REAGENT LOT NUMBER WAS 934751. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE GLUCOSE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED A SAMPLE PROBE. ALL PROBES WERE ADJUSTED. THE LAMP AND CELLS WERE REPLACED AND THE LAMP WAS RE-CALIBRATED. AN INSTRUMENT CHECK WAS COMPLETED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED FOR CHOLESTEROL ON A COBAS C 703 ANALYTICAL UNIT. THE SECOND SAMPLE ALSO HAD DISCREPANT RESULTS FOR GLUCOSE HK GEN.3. THE CUSTOMER REPEATED THE SAMPLES AS THE INITIAL VALUES DID NOT AGREE WITH THE PREVIOUS RESULTS OF THE PATIENTS. THE REPEAT RESULTS WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 1.30 MMOL/L AND IT REPEATED AS 5.31 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 1.94 MMOL/L AND A GLUCOSE VALUE OF 1.40 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN A CHOLESTEROL VALUE OF 5.10 MMOL/L AND A GLUCOSE VALUE OF 4.34 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533560 COBAS C 703 ANALYTICAL UNIT ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ROCHE DIAGNOSTICS C703 07613336200544

    Patients

    Seq Age Sex Outcome Treatment
    1