BEUDAMED
    FDA Adverse Event Summary report: N

    HITACHI MODULAR P

    MDR report key: 669785 · Received September 9, 2005

    Report

    Report Number
    1823260-2005-02704
    Date Received
    September 9, 2005
    Date of Event
    September 7, 2005
    Report Date
    September 7, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL RESULT FOR A PT GLUCOSE WAS O MG/DL. WHEN REPEATED, THE RESULT WAS 165 MG/DL. THE INCORRECT RESULT WAS NOT USED TO GUIDE TREATMENT. THE FIELD SERVICE REP FOUND THAT A VACUUM TUBE WAS PINCHED AND REPAIRED THE INSTRUMENT BY FREEING THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI MODULAR P CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *