BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 21941486 · Received May 1, 2025

    Report

    Report Number
    1823260-2025-01343
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 14, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AST, CREATININE, AND GLUCOSE REAGENTS' LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THAT THE GEAR PUMP HEAD (GPH) PRESSURE WAS LOW, AND THE TUBE IN THE RINSE UNIT WAS DAMAGED. HE ADJUSTED THE GPH PRESSURE AND REPLACED THE TUBE IN THE RINSE UNIT. HE ALSO CHECKED THE PHOTOMETER, VERIFIED THE WASHING LEVELS OF CUVETTES (DETERGENTS AND WATER), AND ADJUSTED THE REAGENT PIPETTES. THE INSTRUMENT WAS OPERATIONAL. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE WAS DUE TO A COMPONENT FAILURE (BROKEN TUBE IN THE RINSE UNIT). THE SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE ENGINEER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH AST ASSAY AND CREATININE ASSAY, 2 PATIENTS' SAMPLES TESTED WITH GLUCOSE ASSAY AND 1 PATIENT SAMPLE TESTED WITH TOTAL CHOLESTEROL ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1: AST: INITIAL RESULT: 108.8 U/L. REPEAT RESULT: 12.7 U/L. CREATININE: INITIAL RESULT: 1.287 MG/DL. REPEAT RESULT: 0.867 MG/DL. SAMPLE 2: GLUCOSE: INITIAL RESULT: 590 MG/DL. 1ST REPEAT RESULT: 85.5 MG/DL. 2ND REPEAT RESULT: 85.7 MG/DL. SAMPLE 3 AND SAMPLE 4 WERE TESTED ON (B)(6) 2025: SAMPLE 3: GLUCOSE: INITIAL RESULT: 626.4 MG/DL. REPEAT RESULT: 90.9 MG/DL. SAMPLE 4: TOTAL CHOLESTEROL: INITIAL RESULT: < 4. REPEAT RESULT: 318.6. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE CUSTOMER NOTICED THAT THE INITIAL RESULTS WERE OUTSIDE THE NORMAL VALUES AND REPEATED THE SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023302 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown