BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 21113326 · Received January 9, 2025

    Report

    Report Number
    1823260-2025-00066
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D1, D2A, D2B, D4, G1 AND G4 WERE UPDATED. THE REACTION CURVE OF THE INITIAL RESULT WAS NOT NORMAL WHICH PROVIDED A HINT OF MEASUREMENT DISTURBANCES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO AN ENVIRONMENTAL ISSUE WHERE VERY BAD DUSTY CONDITIONS WERE IDENTIFIED AT THE CUSTOMER'S SITE.

    Additional Manufacturer Narrative · 0

    THE GLUC3 REAGENT LOT NUMBER WAS 812051. THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT THERE WERE VERY DUSTY CONDITIONS IN THE CUSTOMER'S LABORATORY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE TESTED FOR GLUC HK GEN.3 (GLUC3) ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 36.56 MMOL/L. THE PHYSICIAN REQUESTED THE SAMPLE TO BE REPEATED. 1ST REPEAT RESULT: 3.25 MMOL/L. THE SAMPLE WAS REPEATED 6 MORE TIMES AND THE REPEAT RESULTS WERE 3.26 MMOL/L, 3.26 MMOL/L, 3.26 MMOL/L, 3.37 MMOL/L, 3.34 MMOL/L, AND 3.35 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416844 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown