BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3042116 · Received April 9, 2013

    Report

    Report Number
    2183996-2013-00616
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 18, 2013
    Report Date
    June 18, 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
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. E1 ERRORS WERE FOUND IN THE HISTORY, AND THE UP BUTTON IS ALWAYS ACTIVE. DUE TO AN EXTERNAL MECHANICAL INFLUENCE, THE SNAP DOME OF THIS BUTTON IS PRESSED THROUGH. THIS SOURCE LED TO AN ALWAYS ACTIVATED UP BUTTON AND UNCLEARABLE E1 ERROR MESSAGES.

    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. DEVICE EVALUATION IS IN PROGRESS.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DISPLAYED AN E1 CARTRIDGE EMPTY ERROR, AND THE ERROR MESSAGE COULD NOT BE CLEARED BY PRESSING THE CHECK BUTTON. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND RECEIVED FOR EVALUATION ON (B)(4) 2013. A PRELIMINARY EVALUATION REVEALED THE UP BUTTON IS ALWAYS ACTIVE AND THIS LED TO THE INABILITY TO CLEAR THE E1 ERROR MESSAGE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145335 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1