BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2833409 · Received October 26, 2012

    Report

    Report Number
    2183996-2011-03153
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    April 10, 2011
    Report Date
    April 10, 2011
    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

    THE 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

    ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S INFUSION DEVICE DISPLAYED E7 (ELECTRONIC ERROR). THE PATIENT CHANGED THE BATTERY IN THE INFUSION DEVICE AND NONE OF THE BUTTONS WOULD RESPOND. THE DEVICE THEN DISPLAYED E8 (POWER INTERRUPT). PRELIMINARY EVALUATION OF THE DEVICE REVEALED THAT THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE MOISTURE ENTERED THE INFUSION DEVICE AND CAUSED DAMAGES TO THE DEVICE'S ELECTRONICS. DUE TO AN EXTERNAL MECHANICAL INFLUENCE, THE SNAP DOME OF THE UP BUTTON IS PRESSED THROUGH. THIS LED TO AN ALWAYS ACTIVATED UP BUTTON AND THEREFORE ALL THE BUTTONS DO NOT REACT ON PRESSURE. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN EVALUATION IS COMPLETE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED.

    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