BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3151438 · Received June 7, 2013

    Report

    Report Number
    2183996-2013-01037
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 29, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CAN BE VERIFIED. RESULT THE UP BUTTON DOES NOT OPERATE. THE CONNECTION OF THE UP FLEX PRINT IS INTERRUPTED.

    Description of Event or Problem · 1

    PATIENT REPORTED THE UP ARROW BUTTON ON THE INFUSION DEVICE DOES NOT WORK. ON FOLLOW UP CALL PATIENT STATED THE SOFT COMPONENTS ARE INTACT. PATIENT REPORTED THE ISSUE HAS BEEN AN INTERMITTENT PROBLEM FOR THE LAST COUPLE OF WEEKS. PATIENT STATED THE UP BUTTON ON THE INFUSION DEVICE NO LONGER WORKS AT ALL. PATIENT IS CURRENTLY USING HER BACKUP PLAN. 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 REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252501 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR