BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 502 MODULE

    MDR report key: 21461348 · Received February 25, 2025

    Report

    Report Number
    1823260-2025-00543
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 15, 2025
    Report Date
    February 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ETHANOL REAGENT LOT NUMBER WAS 834091. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER DETERMINED THERE WAS AN ISSUE WITH THE RINSE HEAD. THE SYSTEM WAS DECONTAMINATED. THE CUSTOMER CONFIRMED THERE WERE NO FURTHER ISSUES AFTER THIS ACTION. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ETHANOL GEN.2 ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN AN ETHANOL VALUE OF < 0.1 MG/DL WITH A DATA FLAG. THE INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AS "NEGATIVE". THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER, RESULTING IN AN ETHANOL VALUE OF 261.4 MG/DL. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 274 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT AND A CORRECTION WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037877 COBAS 8000 COBAS C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male