BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1693867 · Received May 19, 2010

    Report

    Report Number
    1823260-2010-03028
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A QUESTIONABLE SODIUM RESULT ON THE COBAS INTEGRA 400 PLUS SYSTEM. INITIAL SODIUM = 133 MMOL/L REPEAT SODIUM (SAME ANALYZER) = 140 MMOL/L REPEAT SODIUM (SAME ANALYZER) = 140 MMOL/L REPEAT SODIUM (DIFFERENT ANALYZER) = 138 MMOL/L THE CUSTOMER STATED THAT THE 133 MMOL/L RESULT WAS NOT RELEASED AND THAT THERE WAS NO AFFECT TO THE PATIENT. THE FIELD SERVICE REPRESENTATIVE STATED THAT THE CAUSE OF THE EVENT WAS, "MAINTENANCE ITEMS NOT SET ON THERE ROTATION IN SYSTEM SOFTWARE, CAUSING MULTIPLE MAINTENANCE ITEMS TO BE WELL PAST DUE." HE CHANGED THE MAINTENANCE WARNINGS IN THE SYSTEM TO MATCH RECOMMENDATIONS IN THE OPERATOR'S MANUAL AND REPLACED PROBES, PIPETTES, MIXING TOWER, ISE TUBING, PIPETTE TIPS, AND REFERENCE SOLUTION. PERFORMANCE CHECKS AND QUALITY CONTROLS WERE PERFORMED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1