BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1052802 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00764
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    December 1, 2007
    Report Date
    May 20, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 05/20/2008, THE PT REPORTED THAT SHE HAS HAD A CHRONIC INFECTION SINCE BEGINNING USE OF HER INFUSION DEVICE IN 2007. IN 2007, A COMPANY REP ARRIVED AT THE PT'S HOME FOR TRAINING AND THE PT REFUSED STATING SHE WOULD USE THE TRAINING WORKBOOK AND WOULD CALL FOR ASSISTANCE IF NEEDED. THREE DAYS PRIOR, THE PT STATED SHE WAS SATISFIED WITH THE WORKBOOK TRAINING. FOUR DAYS LATER, THE PT REPORTED SHE HAD EXPERIENCED A CONTINUOUS INFECTION DUE TO THE INFUSION DEVICE AND SHE DID NOT WISH TO BE CONTACTED AGAIN. THE PT DID NOT PROVIDE INFO ON THE DETAILS OF THE INFECTION OF DATES OF EVENTS. NO BLOOD GLUCOSE ISSUES WERE REPORTED. 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 DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN