BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 20052220 · Received August 23, 2024

    Report

    Report Number
    1823260-2024-02464
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 23, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER PERFORMED ISE AND SIPPER CIRCUIT CLEANING. HE RAN CALIBRATION AND A PRECISION CHECK. THE INVESTIGATION DID NOT IDENTIFY THE SPECIFIC CAUSE OF THE EVENT. THE ISSUE APPEARED TO BE RESOLVED BY THE SERVICE ACTIONS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS 6000 C501 MODULE. THE SAMPLE RESULTS WERE HIGH, SO THE CUSTOMER REPEATED THEM ON ANOTHER C 311 SYSTEM OR THE SAME COBAS C 501. AN EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 160 MMOL/L AND REPEAT RESULTS OF 160, 145, AND 150 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743173 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown