BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2141054 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01627
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 13, 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. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE FOR 3-4 WEEKS AND SHE BELIEVES THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. FOR EXAMPLE ON (B)(6) 2011, HER BLOOD GLUCOSE MEASURED 480 MG/DL IN THE MORNING AND SHE CHANGED THE INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE. HER NORMAL BLOOD GLUCOSE RANGE IS 80-100 MG/DL. SHE NORMALLY CHANGES THE INSULIN CARTRIDGE EVERY 3 DAYS AND THE INFUSION TUBING EVERY 5-6 DAYS. NO FURTHER INFO IS AVAILABLE. THE PT 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 EVAL.

    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 49 YR INSULIN| INSULIN INFUSION SET