BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800 GLUCOSE HK GEN 3

    MDR report key: 1780410 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08062
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    September 12, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH GLUCOSE VALUES FROM ONE INSTRUMENT THAT DO NOT FIT IN CLINICAL PICTURE. THE SAME PATIENT TESTED ON A DIFFERENT INSTRUMENT GIVES DIFFERENT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6)2007 AT 1900H, INITIAL RESULT 4.0 MMOL/L. SAME PATIENT TESTED USING DIFFERENT METHOD AT 20:04H GAVE RESULT OF 12.4 MMOL/L. TESTED AGAIN AT 23:54 H, GAVE RESULT OF 9.7 MMOL/L. ON (B)(6)2007 SAME PATIENT TESTED AT 0600H, INITIAL RESULT 1.9 MMOL/L. PATIENT RETESTED USING DIFFERENT METHOD AT 0553H GAVE RESULT OF 8.83 MMOL/L. ON (B)(6)2007 AT 07:20H, INITIAL RESULT WAS 2.1 MMOL/L. PATIENT ALSO TESTED USING DIFFERENT METHOD AT 0720H, GAVE RESULT OF 10.6 MMOL/L. IF ADDITIONAL INFORMATION IS RECEIVED APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 GLUCOSE HK GEN 3 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA HEPARINE| PANTOZOL| THYRAX| MOVICOLON| PRAVASTATINE| NORMISON| MEDACINASE| RENAGEL| MULTI VITAMIN