BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2120439 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01589
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    March 10, 2011
    Report Date
    May 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 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 ON 2 OCCASIONS. THE FIRST INSTANCE (DATE UNK) HER BLOOD GLUCOSE MEASURE OVER 600 MG/DL AND SHE RECEIVED AN INSULIN INFUSION FROM HER DIABETES SPECIALIST. APPROX 2 MONTHS AGO HER BLOOD GLUCOSE MEASURED 980 MG/DL AND SHE FELT VERY SICK AND VOMITED. SHE WAS TRANSPORTED BY AMBULANCE TO THE HOSP (TREATMENT RECEIVED WAS NOT PROVIDED). THE PT BELIEVES THE INFUSION DEVICE DOES NOT ACCURATELY DELIVER INSULIN AND DOES NOT PROPERLY DISPLAY E6 (MECHANICAL) ERROR OR E4 (OCCLUSION) ERROR. THE INFUSION DEVICE WAS 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 30 YR Hospitalization| O| R INSULIN| INSULIN INFUSION SET