BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 22915636 · Received August 28, 2025

    Report

    Report Number
    1823260-2025-02654
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION, WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE GLUCOSE REAGENT LOT NUMBER WAS 803139. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QC WERE ACCEPTABLE. MANY ALARMS WERE OBSERVED DURING A REVIEW OF THE ALARM TRACE DATA FROM (B)(6) 2025 ("CELL BLANK OUT OF LIMITS", "ABNORMAL PROBE SUCKING", "SAMPLE SHORT", AND "ABNORMAL REMAINING VOLUME OF DILUENT"). THESE ALARMS SUGGEST ISSUES WITH THE CUVETTES, THE SAMPLE PROBE, OR PARTICLES OR CLOTS IN THE SAMPLE. SEVERAL CALIBRATION ALARMS WERE OBSERVED. A GENERAL REAGENT ISSUE IS NOT SUSPECTED, AS ONLY ONE PATIENT SAMPLE WAS AFFECTED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, THE EVENT IS CONSISTENT WITH EITHER A MAINTENANCE ISSUE OR PRE-ANALYTICAL HANDLING ISSUES. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE FIELD SERVICE REPRESENTATIVE CHECKED THE RINSE ASSEMBLY AND FOUND THAT SEVERAL NOZZLES WERE VERY CLOSE TO THE EDGE OF THE CUVETTES. HE PERFORMED ADJUSTMENTS, REPLACED THE CUVETTES, AND CHECKED WATER LEVELS. HE PERFORMED A CELL BLANK TEST WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE SAMPLE WAS INITIALLY TESTED TWICE, AND BOTH RESULTS WERE <0.11 MMOL/L. THE SAMPLE WAS TESTED ON ANOTHER MODULE, AND THE REPEATED RESULT WAS 5.13 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246913 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 803139 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male