BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2210183 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01983
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT FOR THE PAST 5 WEEKS, SHE OFTEN EXPERIENCES ELEVATED BLOOD GLUCOSE OF "HI" MG/DL AND KETOSIS. SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW AND THAT THE INFUSION DEVICE DOES NOT PROPERLY DISPLAY E4 OCCLUSION ERRORS. PATIENT HAS REMOVED THE INFUSION NEEDLE AND PROGRAMMED A 1 I.E. BOLUS, AND INSULIN FLOWED OUT. HYPERGLYCEMIA IS TREATED BY CHANGING THE ACCESSORIES AND DELIVERING INSULIN THROUGH THE INFUSION DEVICE. PATIENT DOES NOT HAVE AN INFECTION AND DID NOT START NEW MEDICATION. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. NORMAL BLOOD GLUCOSE IS 130 MG/DL. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INSULIN| INSULIN INFUSION SET