BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2151662 · Received June 28, 2011

    Report

    Report Number
    2183996-2011-01883
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 2, 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. 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 PATIENT REPORTED BEING HOSPITALIZED IN INTENSIVE CARE FROM (B)(6) 2011 AND WAS THEN TRANSFERRED TO REGULAR CARE ON (B)(6) 2011. THE PATIENT'S BLOOD GLUCOSE WAS VERY HIGH AND WHEN THE INFUSION SET WAS REMOVED THE HEADSET CANNULA WAS KINKED. THE PATIENT'S DOCTOR BELIEVES THE E4 (OCCLUSION) ERROR IS NOT CORRECTLY DISPLAYED. THE PATIENT'S DIET COUNSELOR CLOSED THE TUBING WITH A CLAMP AND BOLUSED AND E4 WAS DISPLAYED AFTER 4 UNITS OF INSULIN WAS DELIVERED. 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 31 YR Hospitalization| R INSULIN INFUSION SET| INSULIN