BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23826654 · Received December 17, 2025

    Report

    Report Number
    1823260-2025-05142
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER WAS 898956 WITH AN EXPIRATION DATE OF 30-NOV-2026. THE FIELD SERVICE ENGINEER (FSE) CHECKED THE INSTRUMENT AND PERFORMED THE FOLLOWING SERVICE ACTIONS: ADJUSTED THE FILL LEVELS OF THE RINSE UNIT. REPLACED THE RIGHT NOZZLE TIP/ VERIFIED ALL SUCTION HOSES, THE GEAR PUMP, THE MAIN WATER PRESSURE, THE PHOTOMETER CHECK, AND THE EXTERNAL PROBE WASH. REPLACED AND ADJUSTED THE SAMPLE PROBES. REPLACED ALL RINSE HOSES ON THE REAGENT PROBES. REPLACED THE VACUUM VALVE ASSEMBLY AND THE BOTTLE. THE FSE THEN PERFORMED A PERFORMANCE CHECK, PRECISION STUDIES, AND QC, AND THEY WERE ALL WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS, SPECIFICALLY REPLACEMENT OF RINSE/WASH HOSE/TUBING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 10 PATIENTS' SAMPLES TESTED WITH CALCIUM GEN.2 ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1: INITIAL RESULT: 1.52 MMOL/L. 1ST REPEAT RESULT: 1.31 MMOL/L. 2ND REPEAT RESULT: 2.16 MMOL/L (TESTED ON ANOTHER MODULE). 3RD REPEAT RESULT: 2.07 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 2: INITIAL RESULT: 1.64 MMOL/L. 1ST REPEAT RESULT: 2.21 MMOL/L, AND THIS RESULT WAS DEEMED TO BE CORRECT. 2ND REPEAT RESULT: 2.27 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 3: INITIAL RESULT: 1.37 MMOL/L. 1ST REPEAT RESULT: 2.25 MMOL/L. 2ND REPEAT RESULT: 2.19 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 4: INITIAL RESULT: 1.24 MMOL/L. 1ST REPEAT RESULT: 2.27 MMOL/L. 2ND REPEAT RESULT: 2.24 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 5: INITIAL RESULT: 1.6 MMOL/L. 1ST REPEAT RESULT: 2.19 MMOL/L. 2ND REPEAT RESULT: 2.27 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 6: INITIAL RESULT: 1.68 MMOL/L. 1ST REPEAT RESULT: 2.39 MMOL/L. 2ND REPEAT RESULT: 2.29 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 7: INITIAL RESULT: 1.65 MMOL/L. 1ST REPEAT RESULT: 2.39 MMOL/L. 2ND REPEAT RESULT: 2.33 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 8: INITIAL RESULT: 1.53 MMOL/L. 1ST REPEAT RESULT: 2.42 MMOL/L. 2ND REPEAT RESULT: 2.35 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 9: INITIAL RESULT: 1.58 MMOL/L. 1ST REPEAT RESULT: 2.4 MMOL/L. 2ND REPEAT RESULT: 2.35 MMOL/L (TESTED ON ANOTHER MODULE). SAMPLE 10: INITIAL RESULT: 1.59 MMOL/L. 1ST REPEAT RESULT: 2.33 MMOL/L. 2ND REPEAT RESULT: 2.19 MMOL/L (TESTED ON ANOTHER MODULE). THE PHYSICIAN QUESTIONED THE INITIAL RESULTS, AND THE SAMPLES WERE THEN REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245674 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown