BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 21296916 · Received February 3, 2025

    Report

    Report Number
    1823260-2025-00319
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) HOSPITAL. THE REAGENT LOT NUMBER IS 823707. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION WAS ACCEPTABLE. THE QC WAS OUT OF RANGE SEVERAL TIMES FOR ALL LEVELS. THE FIELD SERVICE REPRESENTATIVE PERFORMED ALIGNMENTS ON THE SAMPLE AND REAGENT PROBES, REPLACED SEALS ON THE SAMPLE AND REAGENT SYRINGES, CONFIRMED GEAR HEAD PUMP PRESSURE, CLEANED THE BATH AND ULTRASONIC MIXERS, REPLACED CUVETTES AND THE LAMP, AND CONFIRMED THE RINSE LEVELS. HE PERFORMED ADJUSTMENTS, CHECKS, AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH A HARDWARE ISSUE BUT THE EXACT ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE PHOS2 RESULTS FOR 8 PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. PATIENT 1: THE INITIAL RESULT WAS 1.1 MMOL/L AND THE REPEATED RESULT WAS 1.59 MMOL/L. PATIENT 2: THE INITIAL RESULT WAS 1.07 MMOL/L AND THE REPEATED RESULT WAS 1.65 MMOL/L. PATIENT 3: THE INITIAL RESULT WAS 1.14 MMOL/L AND THE REPEATED RESULT WAS 1.67 MMOL/L. PATIENT 4: THE INITIAL RESULT WAS 1.45 MMOL/L AND THE REPEATED RESULT WAS 1.96 MMOL/L. PATIENT 5: THE INITIAL RESULT WAS 1.07 MMOL/L AND THE REPEATED RESULT WAS 1.56 MMOL/L. PATIENT 6: THE INITIAL RESULT WAS 1.3 MMOL/L AND THE REPEATED RESULT WAS 1.82 MMOL/L. PATIENT 7: THE INITIAL RESULT WAS 1.63 MMOL/L AND THE REPEATED RESULT WAS 1.12 MMOL/L. PATIENT 8: THE INITIAL RESULT WAS 0.76 MMOL/L AND THE REPEATED RESULT WAS 1.26 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359585 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown