BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170861 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01904
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 14, 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, THE INFUSION DEVICE PISTON ROD IS DAMAGED AND THE DEVICE DELIVERS TOO LITTLE INSULIN. ON (B)(6) 2011, HIS BLOOD GLUCOSE MEASURED 380 MG/DL AT 11:00 PM AND HE BOLUSED THROUGH THE INFUSION DEVICE WITH NO SUCCESS. ON (B)(6) 2011, HIS BLOOD GLUCOSE MEASURED 345 MG/DL IN THE MORNING AND HE WAS POSITIVE FOR KETONES. AT 9:00 AM, HE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET. HIS BLOOD GLUCOSE REMAINED ELEVATED THE REST OF THE DAY. IN THE AFTERNOON, HE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AGAIN. HE STATED, HE CHECKED THE INFUSION SET AND ONLY TINY DROPS OF INSULIN CAME OUT OF THE TUBING. THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE WAS WET. HE SWITCHED TO HIS BACKUP INFUSION DEVICE AND HE HAD NO FURTHER ISSUES. HIS NORMAL BLOOD GLUCOSE RANGE IS 90 - 130 MG/DL. 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR INSULIN INFUSION SET| INSULIN