BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803117 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01621
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 18, 2012
    Report Date
    May 10, 2013
    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
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. RESULT THE SOFTCOMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE PUMP ELECTRONICS. THE BUTTONS PASSED THE FUNCTIONAL INVESTIGATION SUCCESSFUL AND COMPLY WITH THE SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    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

    PATIENT REPORTED THE PROTECTIVE RUBBER ON THE UP BUTTON IS WORN AND THE BUTTON HAS TO BE PRESSED HARD AND AT A PARTICULAR ANGLE FOR THE INFUSION DEVICE TO RESPOND. PATIENT REPORTED THE DOWN BUTTON IS STARTING TO ACT SIMILARLY. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 INFUSION PUMP| INSULIN