BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2141043 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01636
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A COMPANY REP DISCOVERED A POSTING ON A SOCIAL NETWORKING WEBSITE WHERE THE PT STATED HE EXPERIENCED ELEVATED BLOOD GLUCOSE OF 400 MG/DL DUE TO NOT RECEIVING INSULIN AND THE INFUSION DEVICE NOT ALERTING HIM THAT INSULIN WAS NOT BEING DELIVERED. THE COMPANY REP ADVISED THE PT TO CONTACT TECHNICAL SUPPORT AND PROVIDED CONTACT INFO. ATTEMPTS TO CONTACT THE PT TO GATHER INFO WERE UNSUCCESSFUL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT 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 SYS INC. NA NA

    Patients

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