BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3200874 · Received July 2, 2013

    Report

    Report Number
    2183996-2013-01196
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. RESULT A2 WAS FOUND IN THE HISTORY LIST. THE SOFTCOMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE PUMP ELECTRONICS. THE BUTTONS WERE TESTED SUCCESSFULLY AND COMPLY WITH THE SPECIFICATION. THE PUMP CORRECTLY TRIGGERED THE A2 ALERT WHEN THE BATTERY WENT EMPTY. 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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE UP/DOWN BUTTONS ON THE INFUSION DEVICE IS NON- FUNCTIONAL. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303370 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR