BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 701 MODULE

    MDR report key: 20895411 · Received December 10, 2024

    Report

    Report Number
    1823260-2024-03604
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 26, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUCOSE REAGENT LOT NUMBER WAS 812051. THE CHOLESTEROL REAGENT LOT NUMBER AND THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND DAMAGED CELL RINSE ASSEMBLY TUBING. THE TUBING WAS REPLACED. A VALVE AND NOZZLE WERE ALSO REPLACED. MAINTENANCE WAS PERFORMED ON THE ANALYZER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE AND THE ISSUE WAS RELATED TO SERVICE MAINTENANCE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH GLUCOSE HK GEN. 3 ON A COBAS 8000 C 701 MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT GLUCOSE RESULTS. A SECOND PATIENT SAMPLE ALSO HAD DISCREPANT CHOLESTEROL RESULTS WHEN TESTED ON THE C 701 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 279.9 MG/L. THE PATIENT WAS CALLED TO THE HOSPITAL WHERE A RAPID TEST FOR GLUCOSE DETERMINATION WAS PERFORMED. THE RAPID TEST GLUCOSE VALUE WAS WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT COMPLAINED ABOUT THE INITIAL SAMPLE VALUE BASED ON THIS AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT ON (B)(6) 2025 WAS 88.2 MG/DL. THE REPEAT VALUE AGREED WITH THE RAPID TEST RESULT. THE SECOND SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 84 MG/DL AND IT REPEATED AS 186 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677868 COBAS 8000 C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female