BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 13893083 · Received March 24, 2022

    Report

    Report Number
    1823260-2022-00852
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STOPPED PERFORMING THE ASSAY ON LINE 2 OF THE SECOND MODULE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE AND REAGENT PROBES. HE CHECKED THE EXTERNAL WASH FOR THE REAGENT PROBES AND DID NOT FIND ANY ISSUES. HE MADE ADJUSTMENTS TO THE SYSTEM SOFTWARE. HE PERFORMED MECHANICAL CHECKS WITH ACCEPTABLE RESULTS. THE MAIN WATER PRESSURE, GEAR-PUMP HEAD (GPH) PRESSURE, AND THE LAUNDRY LEVELS WERE WITHIN SPECIFICATIONS. ROUTINE OPERATIONS WERE RESUMED AFTER SUCCESSFUL CALIBRATION AND QC RESULTS WERE OBTAINED. AFTER THE FSE REPLACED THE PROBES, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS CONSISTENT WITH A MAINTENANCE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE MG2 MAGNESIUM GEN.2 RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE HIGH RESULT WAS NOTED IN LINE 2 OF THE 2ND MODULE. THE SAMPLE WAS RERUN ON THE FIRST AND SECOND MODULES OF THE ANALYZER. THE INITIAL RESULT FROM LINE 2 OF THE SECOND MODULE WAS 1.07 MMOL/L. THE REPEAT RESULT FROM THE FIRST AND SECOND MODULES WAS 0.81 MMOL/L. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418873 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown