BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3070466 · Received April 22, 2013

    Report

    Report Number
    2183996-2013-00717
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 16, 2013
    Report Date
    November 27, 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
    GR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT E8 WAS FOUND IN THE HISTORY LIST. THE SOFTCOMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND DESTROY THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON IS PERMANENT ACTIVE DUE TO AN EXTERNAL MECHANIC DAMAGE. AS RESULT OF THE DEFECTIVE BUTTON THE PUMP CORRECTLY TRIGGERED AN UNCLEARABLE E8 ERROR MESSAGE. AS FURTHER RESULT OF THE PERMANENT ACTIVATED UP BUTTON THE OTHER BUTTONS DO NOT RESPOND TO COMMANDS. 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 INFUSION DEVICE DISPLAYED AN E8 (POWER INTERRUPT) ERROR MESSAGE. PRELIMINARY EVALUATION ON (B)(4) 2013 REVEALS THE E8 COULD NOT BE CONFIRMED BECAUSE OF FLAT PRESSED BUTTONS ON THE INFUSION DEVICE. 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. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173086 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1