BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2172417 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01794
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 15, 2011
    Report Date
    May 27, 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

    THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF UP TO "HI" ON HER BLOOD GLUCOSE MONITOR AT LEAST ONCE PER WEEK FOR 10 WEEKS. SHE BELIEVES THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. SHE WAS POSITIVE FOR KETONES AND FELT NAUSEOUS AND VOMITED. SHE BOLUSED THROUGH THE INFUSION DEVICE BUT WAS UNABLE TO LOWER HER BLOOD GLUCOSE. SHE INJECTED INSULIN VIA PEN AND CHANGED ALL OF THE ACCESSORIES OF THE INFUSION DEVICE. HER NORMAL BLOOD GLUCOSE RANGE IS 7-7.5 MMOL/L (126-135 MG/DL). THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 29 YR INSULIN INFUSION SET| INSULIN