BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2190345 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02104
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 15, 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

    THE PT'S MOTHER REPORTED THAT THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 500 MG/DL FOR 3-4 WEEKS DESPITE BOLUSING AND SHE BELIEVES THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. ON (B)(6) 2011 AT 11:00PM, HER BLOOD GLUCOSE MEASURED 343 MG/DL AND THE MOTHER BOLUSED 5 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT 1:00AM ON (B)(6) 2011, HER BLOOD GLUCOSE MEASURED 285 MG/DL AND THE MOTHER BOLUSED 2 UNITS OF INSULIN, AT 2:00AM HER BLOOD GLUCOSE MEASURED 314 MG/DL AND THE MOTHER BOLUSED 2.5 UNITS OF INSULIN AND SHE CHANGED THE INFUSION SITE AND TUBING. AT 4:00AM HER BLOOD GLUCOSE MEASURED 352 MG/DL AND THE MOTHER BOLUSED 6 UNITS OF INSULIN. AT 6:00AM HER BLOOD GLUCOSE MEASURED 355 MG/DL AND THE MOTHER BOLUSED 6 UNITS OF INSULIN AND CHANGED THE INSULIN CARTRIDGE. AT 8:00AM HER BLOOD GLUCOSE MEASURED 438 MG/DL AND THE MOTHER BOLUSED 6 UNITS OF INSULIN, AT 9:00AM HER BLOOD GLUCOSE MEASURED 365 MG/DL AND THE MOTHER BOLUSED (AMOUNT UNK), AT 10:00AM HER BLOOD GLUCOSE MEASURED 359 MG/DL AND THE MOTHER BOLUSED 7 UNITS OF INSULIN. AT 2:00PM THE PT SWITCHED TO THE BACKUP INFUSION DEVICE AND THE PT'S BLOOD GLUCOSE DECREASED. THE PT'S NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    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 Required Intervention INSULIN| INSULIN INFUSION SET