BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3220851 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01254
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 30, 2013
    Report Date
    September 9, 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DOWN 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 DOWN BUTTON AND UNCLEARABLE E8 ERROR MESSAGES. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT AFTER THE PATIENT CHANGED THE BATTERY IN HER INFUSION DEVICE, THE DEVICE DISPLAYED E8 (POWER INTERRUPT) AND THE CHECK BUTTON WOULD NO LONGER FUNCTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320415 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR