BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2142929 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01884
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    March 22, 2011
    Report Date
    June 9, 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 REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF OVER 600 MG/DL ON (B)(6) 2011 WHILE SKIING. ON (B)(6) 2011, THE PT WAS TAKEN BY AMBULANCE TO THE HOSPITAL UNTIL (B)(6) 2011. THE PT'S MOTHER THEN MOVED THE PT TO ANOTHER HOSPITAL UNTIL (B)(6) 2011. ON (B)(6) 2011, E4 (OCCLUSION) ERROR WAS DISPLAYED ON THE INFUSION DEVICE AT 2:00AM AND THE PT'S BLOOD GLUCOSE MEASURED 290 MG/DL. THE PT CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND BOLUSED 2 UNITS OF INSULIN. AT 2:30AM, E4 WAS AGAIN DISPLAYED AND THE PT CHANGED THE INFUSION SET. AT 5:30AM, E4 WAS DISPLAYED AND THE PT CHANGED THE INFUSION SET. AT 7:00AM, THE PT FELT SICK AND HAD A STOMACH ACHE, HER BLOOD GLUCOSE MEASURED 309 MG/DL AND SHE WAS POSITIVE FOR KETONES. SHE BOLUSED 9.7 UNITS OF INSULIN THROUGH THE INFUSION DEVICE AND ATE. AT 9:00AM, HER BLOOD GLUCOSE MEASURED 558 MG/DL AND AT 9:45AM MEASURED 638 MG/DL. THE PT WAS TAKEN TO THE HOSPITAL BY HER MOTHER AND WAS TREATED WITH AN IV. ON (B)(6) 2011 AT 6:00AM, THE PT SWITCHED TO HER BACKUP INFUSION DEVICE. SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011 AT 2:30PM. HER NORMAL BLOOD GLUCOSE LEVEL IS 120 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 Hospitalization| O| R INSULIN INFUSION SET| (DATE OF TX (B)(6))| INSULIN (DATE OF TX (B)(6))