BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2070272 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01118
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 24, 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
    IT
    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

    PATIENT REPORTED 2 HOURS AFTER CHANGING THE INFUSION SET ON (B)(6) 2011, HE BECAME ILL. PATIENT STATED HIS BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND HE WAS BROUGHT INTO THE EMERGENCY ROOM AT THE HOSPITAL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED THE DOCTORS TREATED HIM WITH MULTI-INJECTION THERAPY. PATIENT STATED HE FELT BETTER SOON AFTER AND THEN REMOVED THE INFUSION SET. PATIENT REPORTED THE INFUSION SET NEEDLE WAS COMPLETELY BENT IN THE MIDDLE. PATIENT STATED THE INFUSION DEVICE DID NOT GIVE ANY ALERTS OR ERROR MESSAGES. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 Hospitalization| O| R INSULIN INFUSION SET| INSULIN