BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2960352 · Received February 6, 2013

    Report

    Report Number
    2183996-2013-00172
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. (B)(4): DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER'S DOCTOR ADVISED HER TO DISCONTINUE USE OF THE INFUSION DEVICE AND TO UTILIZE INJECTION THERAPY. THE PATIENT HAD BEEN IN THE HOSPITAL ON (B)(6) 2013 WITH AN ELEVATED BLOOD GLUCOSE LEVEL OF 678 MG/DL. HER NORMAL RANGE IS 70-120 MG/DL. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, BUT RECEIVED AN IV OF INSULIN TO TREAT THE ELEVATED BLOOD GLUCOSE LEVEL. THE DOCTOR STATED THAT THE INFUSION DEVICE WAS NOT DELIVERING ENOUGH INSULIN. THE PATIENT HAS NOT HAD ANY LIFESTYLE CHANGES. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49441 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR Hospitalization| R INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN