BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2012096 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00384
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 18, 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 OF 180-251 WHILE USING THIS INFUSION DEVICE. HIS NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. HE ATTEMPTED TO BOLUS THROUGH THE INFUSION DEVICE TO LOWER HIS BLOOD GLUCOSE BUT WAS UNSUCCESSFUL. ON (B)(6) 2011, HE SWITCHED TO HIS PREVIOUS INFUSION DEVICE USING THE SAME BASAL RATES AND HIS BLOOD GLUCOSE DECREASED. HE BELIEVES, THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. 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 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 76 YR INSULIN INFUSION SET| INSULIN