BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2202485 · Received August 5, 2011

    Report

    Report Number
    2183996-2011-02176
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 27, 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 THE UNITED STATES. INFO 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 THE PT HAS EXPERIENCED ELEVATED BLOOD GLUCOSE OVER THE PAST 3 WEEKS, AND MOTHER BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW AND THE INFUSION DEVICE DOES NOT CORRECTLY DISPLAY E4 OCCLUSION ERRORS. PT FELT SICK, AND MOTHER WAS ABLE TO PROVIDE TREATMENT FOR HYPERGLYCEMIA. MOTHER CHECKED THE INFUSION SET AND NOTICED A LOT OF AIR BUBBLES, BUT THE INFUSION SET WAS NOT CLOGGED. MOTHER PROVIDED THE FOLLOWING INFO AS AN EXAMPLE: THE INFUSION SET WAS CHANGED ON (B)(6) 2011 AT 2:30 PM. ON (B)(6) 2011 AT 11:42 AM, BLOOD GLUCOSE WAS 345 MG/DL. MOTHER STOPPED THE INFUSION DEVICE AND CHANGED THE INFUSION SET. THERE WAS NO OCCLUSION OR INSULIN LEAKAGE, AND MOTHER ADMINISTERED 2 IU OF INSULIN VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 352 MG/DL AT 1 PM, AND PT ATE 6 BE AND MOTHER ADMINISTERED 7.5 IU OF INSULIN VIA THE INFUSION DEVICE. PT DID NOT HAVE AN INFECTION OR START NEW MEDICATION. NORMAL BLOOD GLUCOSE IS 120 MG/DL. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. THE CORRECT TYPE OF BATTERY IS USED, AND THE BATTERY SETTING IS PROGRAMMED CORRECTLY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADD'L 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 12 YR Required Intervention INSULIN INFUSION SET| INSULIN