BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2012969 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00456
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 3, 2011
    Report Date
    March 2, 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
    NL
    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'S PARENT BELIEVES THE INFUSION DEVICE DOES NOT DELIVER BOLUSES PROPERLY DUE TO ELEVATED BLOOD GLUCOSE OF 30 MMOL/L (540 MG/DL). THE PT BOLUSED 4 UNITS OF INSULIN AND HER BLOOD GLUCOSE DECREASED TO 19 MMOL/L (342 MG/DL). THE PT SWITCHED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE DECREASED. 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 EVALUATION.

    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 9 YR INSULIN INFUSION PUMP| INSULIN