BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 22925882 · Received August 29, 2025

    Report

    Report Number
    1823260-2025-02673
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR'S B5 DESCRIBE EVENT OR PROBLEM, THE UNIT OF MEASUREMENT FOR THE PREVIOUSLY REPORTED CREATININE RESULTS IS UMOL/L. A FIELD SERVICE ENGINEER (FSE) PERFORMED SAMPLE PROBE ADJUSTMENTS, ADJUSTED THE GEAR PUMP HEAD, CHECKED REAGENT PROBE ALIGNMENTS, DETERGENT LEVELS, AND THE ULTRASONIC MIXER PERFORMANCE. THE FSE ALSO REMOVED AND CHECKED THE VACUUM PUMP DIAPHRAGM, RAN THE PHOTOMETER, AND CELL BLANK. IN ANOTHER VISIT, THE FSE REPLACED THE LAUNDRY SOLENOIDS OF THE SAMPLE VALVE ASSEMBLY, REALIGNED ALL OF THE SYRINGES, AND REPLACED REAGENT SEALS. QC WAS COMPLETED AND PASSED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER WAS 841368. THE CREATININE REAGENT LOT AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR ONE PATIENT SAMPLE AND A DISCREPANT CREATININE ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C 702 MODULE. SAMPLE 1: THE INITIAL CALCIUM RESULT WAS 13.37 MMOL/L. THE FIRST REPEAT CALCIUM RESULT WAS 2.25 MMOL/L. THE SECOND REPEAT CALCIUM RESULT WAS 2.24 MMOL/L. SAMPLE 2: THE INITIAL CREATININE RESULT WAS 49. THE REPEAT CREATININE RESULT WAS 90. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222737 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown