BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2182551 · Received July 19, 2011

    Report

    Report Number
    2183996-2011-02076
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    MOTHER REPORTED, PT HAS EXPERIENCED ELEVATED BLOOD GLUCOSE OVER THE PAST 3-4 WEEKS DUE TO THE INSULIN DELIVERY OF THE INFUSION DEVICE BEING TOO LOW. ON THE MORNING OF (B)(6) 2011, BLOOD GLUCOSE WAS 540 MG/DL. PT CHANGED THE INFUSION SET AND DELIVERED INSULIN VIA PEN AS A CORRECTION. BLOOD GLUCOSE THEN ELEVATED TO 570 MG/DL, AND NORMAL BLOOD GLUCOSE IS 80-100 MG/DL. PT WAS HOSPITALIZED FOR 4 DAYS AS A RESULT. CORRECT TYPE OF BATTERY IS USED IN THE INFUSION DEVICE. PT DID NOT HAVE AN INFECTION OR START NEW MEDICATION. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R INSULIN INFUSION SET| (DATE OF TX (B)(6))| INSULIN (DATE OF TX (B)(6))