BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23567753 · Received November 17, 2025

    Report

    Report Number
    1823260-2025-04655
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 18, 2025
    Report Date
    March 31, 2026
    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

    THE CALCIUM GEN.2 REAGENT LOT NUMBER WAS 882078. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE CREATININE PLUS VER.2 REAGENT LOT NUMBER WAS 889247. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE UREA/BUN REAGENT LOT NUMBER WAS 867715. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT THE SAMPLE PROBES A AND B WERE NOT BEING WASHED PROPERLY, THE REAGENT PROBES R1A AND R2B WERE NOT BEING WASHED CORRECTLY, AND BUILDUP WAS OBSERVED ON THE ULTRASONIC MIXERS. THE FSE FIXED THE IDENTIFIED ISSUES AND CLEANED, ADJUSTED, AND REPLACED MULTIPLE MECHANICAL AND FLUIDIC COMPONENTS, INCLUDING AIR/VACUUM DIAPHRAGMS, BATH SENSOR, DEGASSER, TUBING, AND PROBES. QC AND CALIBRATION RESULTS WERE ACCEPTABLE FOLLOWING THE INTERVENTIONS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE UREA/BUN RESULTS IN MEDWATCH FIELD B5, AS THE INITIAL AND REPEAT RESULTS WERE SWITCHED. THE QUESTIONED RESULTS SHOULD BE: UREA/BUN: THE INITIAL RESULT WAS 6.5 MMOL/L. THE REPEAT RESULT WAS 18.5 MMOL/L. ON (B)(6) 2025, TWO ADDITIONAL SAMPLES WERE ALLEGED TO HAVE GENERATED QUESTIONABLE RESULTS FOR THE CREATININE PLUS VER.2 AND UREA/BUN ASSAYS: CREATININE PLUS VER.2: THE INITIAL RESULT WAS 270 UMOL/L. THE REPEAT RESULT WAS 83 UMOL/L. UREA/BUN: THE INITIAL RESULT WAS 0.5 MMOL/L. THE REPEAT RESULT WAS 10.2 MMOL/L.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH MULTIPLE ASSAYS FOR SEVERAL PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: CALCIUM GEN.2: THE INITIAL RESULT WAS 1.82 MMOL/L. THE REPEAT RESULT WAS 2.21 MMOL/L. CREATININE PLUS VER.2: THE INITIAL RESULT WAS 743 UMOL/L. THE REPEAT RESULT WAS 203 UMOL/L. UREA/BUN: THE INITIAL RESULT WAS 18.5 MMOL/L. THE REPEAT RESULT WAS 6.5 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71066 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown