BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3040953 · Received April 8, 2013

    Report

    Report Number
    2183996-2013-00611
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    May 22, 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. E8 POWER INTERRUPT ERRORS WERE FOUND IN THE HISTORY LIST. THE UP BUTTON IS PERMANENTLY ACTIVATED DUE TO AN EXTERNAL MECHANICAL INFLUENCE, AND THE SNAP DOME OF THE UP BUTTON IS PRESSED THROUGH. THIS ISSUE LED TO THE PERMANENTLY ACTIVATED UP BUTTON AND AN UNCLEARABLE E8 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.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DISPLAYED AN E7 ELECTRONIC ERROR IN THE RUN MODE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS RETURNED TO THE FIRST LEVEL INVESTIGATION UNIT ON (B)(6) 2013. AN E8 POWER INTERRUPT ERROR APPEARED DURING STARTUP, AND THE ERROR MESSAGE COULD NOT BE CLEARED DUE TO A FLAT-PRESSED UP BUTTON. THE INFUSION DEVICE WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2013, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143026 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR