BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2770134 · Received September 28, 2012

    Report

    Report Number
    2183996-2012-01474
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    April 29, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION DEVICE DISPLAYED AN E10 CARTRIDGE ERROR WHEN SHE CHANGED THE CARTRIDGE AND THE "PLUNGER" WAS BLOCKED. SHE VERIFIED THE TYPE AND CHANGED THE BATTERY, BUT THIS DID NOT RESOLVE THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND RETURNED FOR EVALUATION. A PRELIMINARY EVALUATION REVEALED THE SOFT COMPONENTS OF THE UP AND DOWN BUTTONS ARE MISSING, AND RESTRICTED HANDLING IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE MAY ENTER THE INFUSION DEVICE AND DESTROY THE FUNCTIONALITY OF THE BUTTONS AND THE ELECTRONICS. THE CARTRIDGE COMPARTMENT IS CONTAMINATED A RESULT OF MISUSE. DUE TO THE CONTAMINATION OF THE PISTON ROD AND CARTRIDGE COMPARTMENT, THE INFUSION DEVICE CORRECTLY TRIGGERED AN E10 CARTRIDGE ERROR. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP