BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170887 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01869
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE DOESN'T BELIEVE THE INFUSION DEVICE IS DELIVERING THE CORRECT AMOUNT OF INSULIN. PT STATED ABOUT 24 HOURS AGO HE RECEIVED A BLOOD GLUCOSE READING IN THE 250-270 MG/DL RANGE. PT REPORTED HE BOLUSED 5.0 UNITS OF INSULIN WHICH SHOULD HAVE BROUGHT HIM DOWN TO HIS TARGET RANGE. PT'S TARGET BLOOD GLUCOSE RANGE IS 70-110 MG/DL. PT STATED WHEN HE BOLUSED, IT ONLY BROUGHT HIS BLOOD GLUCOSE DOWN 20 POINTS. PT REPORTED, HE THEN BOLUSED ANOTHER 5.0 UNITS OF INSULIN AND IT BROUGHT HIM DOWN TO HIS TARGET RANGE. PT STATED, HE RECEIVED NO ERROR MESSAGES ON THE INFUSION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND PT REPORTED HE HAS RETURNED THE ALLEGED PRODUCT 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 42 YR INSULIN| INSULIN INFUSION SET