BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1133409 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06364
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATOR EXPERIENCED DISCREPANT SODIUM RESULTS FOR THREE PATIENT SAMPLES, ONE EXAMPLE WAS PROVIDED. INITIAL RESULT WAS 137 MMOL/L. SAME SAMPLE REPEATED TWICE GAVE 132 AND 131 MMOL/L. THE INITIAL RESULT WAS REPORTED. THE PT'S SODIUM CHLORIDE TREATMENT WAS CHANGED DURING THE LAST THREE DAYS, BUT IT WAS UNCLEAR IF IT WAS DUE TO THE REPORTED RESULT. PATIENTS WERE NOT ADVERSELY AFFECTED BY THE ISSUE. THE FIELD SERVICE REP DETERMINED CELLULAR DEBRIS IN SAMPLE MATERIAL AND CONSUMABLE ITEMS WERE AFFECTING THE PIPETTING SYSTEM. HE REPLACED THE SAMPLE SYRINGES, SAMPLE PROBES, THE ISE TUBING AND THE MIX TOWER. THE TECHNICAL SERVICE REP ALSO ASSISTED BY PERFORMING CORRELATION STUDIES WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR LIPITOR - 20 MG| VANCOMYCIN IV| LABITOL - 20 MG| TRANDATE - 20 MG| NACI IV - DOSAGE LISTED| ROCEPHIN - 2 GMS