BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3121520 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00882
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    October 8, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND DESTROYS THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP AND DOWN BUTTON ARE PERMANENT ACTIVE DUE TO AN EXTERNAL MECHANIC DAMAGE. IT IS NOT POSSIBLE TO CONFIRM THE TRIGGERED E8 ERROR MESSAGE (POWER INTERRUPT), BECAUSE OF THE PERMANENT ACTIVATED UP AND DOWN BUTTON THE OTHER BUTTONS DO NOT RESPOND TO COMMANDS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(4) 2013 PATIENT REPORTED THE BUTTONS ON THE INFUSION DEVICE ARE NOT RESPONDING TO PRESS THIS MORNING WHEN PRESSING THE MENU, CHECK BUTTON, OR THE UP/DOWN ARROW BUTTONS. PATIENT STATED THE INFUSION DEVICE FROZE IN THE START MODE SCREEN WITH THE TIME/DATE AND BASAL RATE UNIT. PATIENT REMOVED THE BATTERY PRIOR TO THE CALL. HAD PATIENT INSTALL A NEW BATTERY AND A NEW BATTERY COVER; DISPLAYED THE E8 (POWER INTERRUPT) ERROR MESSAGE. PATIENT REPORTED WHEN THE CHECK MARK BUTTON IS PRESSED TWICE THERE IS NO RESPONSE TO CLEAR THE E8. PATIENT STATED THERE WERE NO AUDIBLE SOUNDS WHEN BUTTONS ARE PRESSED. PATIENT REPORTED THE ISSUE IS CONSTANT FAILURE WHICH BEGAN THIS MORNING. PATIENT STATED THE BUTTONS DO NOT RESPOND WHEN PRESSED DOWN HARD AND DO NOT REMAIN FLAT. ASSISTED WITH SETTING UP THE BACKUP INFUSION DEVICE. 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
    224636 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR PRAVASTATIN| CLONIDINE| FLUDROCORTISONE| APIDRA INSULIN| SYNTHROID| HYDROCORTISONE| AMLODIPINE| ENALAPRIL| LOSARTAN| POTASSIUM