BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 20578179 · Received October 31, 2024

    Report

    Report Number
    1823260-2024-03146
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    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 REAGENT LOT NUMBER IS 801953. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND REPLACED THE GEAR PUMP. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A GEAR PUMP ISSUE. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE PHOS2 (PHOSPHORUS) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 6 MG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 4 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012353 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown