BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2011886 · Received February 9, 2011

    Report

    Report Number
    2183996-2011-00164
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION DEVICE IS NOT DELIVERING INSULIN. PT STATED SHE DISCONNECTED FROM THE INFUSION SITE, PROGRAMMED A BOLUS OF 1.5 UNITS OF INSULIN AND NOTHING COME OUT OF THE INFUSION TUBING. PT REPORTED SHE THEN PROGRAMMED A BOLUS OF 10.0 UNITS OF INSULIN AND ONLY 2 DROPS OF INSULIN CAME OUT OF THE INFUSION TUBING. PT STATED SHE DID NOT RECEIVE AN ERROR MESSAGE. PT DECLINED TO TROUBLESHOOT THE INFUSION DEVICE. ON FOLLOW UP CALL ON (B)(6) 2011, PT REPORTED HER BLOOD GLUCOSE HAS COME BACK DOWN AND THE NEW INFUSION DEVICE IS WORKING. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 31 YR INSULIN INFUSION SET| INSULIN