BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1915762 · Received November 29, 2010

    Report

    Report Number
    2183996-2010-02493
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 23, 2010
    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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 200-300 MG/DL SINCE (B)(6) 2010. THE PT CHANGED THE INFUSION SET AND INSULIN CARTRIDGE AND BOLUSED THROUGH THE INFUSION DEVICE BUT WAS UNABLE TO LOWER HER BLOOD GLUCOSE. THE PT FELT SICK AND VOMITED. ON (B)(6) 2010, THE PT WAS HOSPITALIZED IN THE REGULAR CARE UNIT UNTIL (B)(6) 2010 AND WAS THEN MOVED TO INTENSIVE CARE UNTIL (B)(6) 2010. SHE WAS THEN MOVED BACK TO THE REGULAR CARE UNIT AND HER BLOOD GLUCOSE IS ELEVATED AGAIN. SHE WAS TREATED WITH AN INSULIN IV. SHE STATED E4 (OCCLUSION) ERROR WAS NOT PROPERLY DISPLAYED ON THE INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 23 YR Hospitalization| R INSULIN INFUSION SET(DATE OF (B)(6))| INSULIN( DATE OF TX (B)(6))