BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243164 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01710
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 26, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PATIENT REPORTED HE HAS RECEIVED THREE E6 (MECHANICAL ERROR) MESSAGES ON HIS INSULIN DEVICE IN THE PAST 3 DAYS. HE STATED THIS EVENING HE TRIED TO CLEAR ANOTHER E6 AND ADVANCE THE PISTON ROD FOR A PARTIALLY FILLED INSULIN CARTRIDGE. THE DEVICE DISPLAYED AN E6 WHEN THE PISTON ROD REACHED 199 UNITS AND AGAIN AT 72 UNITS. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO INSERT A NEW BATTERY AND TO RESET THE DEVICE. THE PATIENT SUCCESSFULLY DID SO WITHOUT THE DEVICE DISPLAYING ANY ERRORS. THE PATIENT IS CONCERNED AS THIS IS A RECURRING ERROR AND DOES NOT BELIEVE IT IS A BATTERY ISSUE. HE STATED HE DOES NOT ATTACH THE ADAPTER AND TUBING TO THE CARTRIDGE PRIOR TO INSERTION AND IS CERTAIN INSULIN HAS SPILLED INTO THE CARTRIDGE CHAMBER. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN