BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2139548 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01753
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 632 MG/DL. THE CALL WAS DISCONNECTED. UPON FOLLOW UP ON (B)(6) 2011, THE PT REPORTED HE WENT TO THE EMERGENCY ROOM DUE TO ELEVATED BLOOD GLUCOSE YESTERDAY. HE ARRIVED AT 7:00PM AND WAS RELEASED AT 1:30AM ON (B)(6) 2011. HE REMAINED CONNECTED TO HIS INFUSION DEVICE AND RECEIVED AN INSULIN IV. HIS NORMAL BLOOD GLUCOSE RANGE IS 150-190 MG/DL. HE STATED HE DOES NOT BELIEVE THE INFUSION DEVICE MALFUNCTIONED AND STRESS, PAIN, AND CHANGES IN MEDICATION CAUSED HIGH READINGS. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT ISSUES. NO PRODUCT WILL 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 44 YR Hospitalization| O| R INSULIN INFUSION SET (TX DATE: (B)(6))| INSULIN (DATE OF TX: (B)(6))