BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3253737 · Received July 30, 2013

    Report

    Report Number
    2183996-2013-01429
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 23, 2013
    Report Date
    September 3, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. E8 ERRORS WERE FOUND IN THE HISTORY LIST. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE ENTERED THE PUMP AND DESTROYED THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON IS PERMANENTLY ACTIVE DUE TO AN EXTERNAL MECHANICAL DAMAGE.

    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 INFUSION DEVICE DISPLAYED AN E8 POWER INTERRUPT ERROR AND THE BUTTONS DO NOT FUNCTION. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356375 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1