BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2090224 · Received May 6, 2011

    Report

    Report Number
    2183996-2011-01307
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 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

    MOTHER REPORTED THAT PATIENT FELT SICK ON (B)(6) 2011, AND WENT TO HER PHYSICIAN. PHYSICIAN THOUGHT PATIENT HAD AN INFECTION AND SUGGESTED "BED REST." ON (B)(6) 2011, PATIENT FELT "VERY SICK" AND DID NOT HAVE COORDINATED MOVEMENT. THE INFUSION TUBING SEPARATED FROM THE INFUSION DEVICE AND WAS HANGING ON A DOOR HANDLE. PATIENT NOTICED THIS BUT WAS UNABLE TO CHANGE HER INFUSION SET. ON (B)(6) 2011, FATHER DROVE TO HER APARTMENT AND CALLED THE FIRE BRIGADE. THE FIRE BRIGADE OPENED THE DOOR AND FOUND THE PATIENT UNCONSCIOUS. PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. MOTHER ADVISED PATIENT MAY BE DISCHARGED ON (B)(6) 2011. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    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 (DATE OF TX: (B)(6))| INSULIN INFUSION SET| INSULIN (DATE OF TX: (B)(6))