BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1212734 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01616
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING AN UNCLEARABLE E6 (MECHANICAL) ERROR ON HIS INFUSION DEVICE. HE ATTEMPTED TO CLEAR THE ERROR BY PERFORMING A CARTRIDGE CHANGE AND RETRACTING THE PISTON ROD, BUT THE PISTON ROD WOULD NOT RETRACT AND THE INFUSION DEVICE MADE A "CLICKING" SOUND. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL 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 62 YR INSULIN INFUSION SET| INSULIN