BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2090194 · Received May 6, 2011

    Report

    Report Number
    2183996-2011-01315
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    October 10, 2010
    Report Date
    April 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 OF 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 THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE OVER THE PREVIOUS 6 MONTHS. SHE ATTEMPTED TO CORRECT HYPERGLYCEMIA USING THE INFUSION DEVICE, BUT THIS WAS NOT SUCCESSFUL. PATIENT CHANGED TO THE BACKUP INFUSION DEVICE, AND BLOOD GLUCOSE WAS "OK." ON (B)(6) 2011, THE BACKUP INFUSION DEVICE REACHED "END OF LIFE." PATIENT SWITCHED BACK TO THE PRIMARY INFUSION DEVICE, AND BLOOD GLUCOSE ELEVATED TO 500 MG/DL. PATIENT ATTEMPTED TO CORRECT HYPERGLYCEMIA USING THE INFUSION DEVICE, BUT THIS WAS NOT SUCCESSFUL. PATIENT FELT SICK AND NAUSEOUS AND WAS DRIVEN TO THE HOSPITAL BY HER MOTHER. PATIENT RECEIVED STATIONARY CARE IN THE REGULAR CARE UNIT (DATES WERE NOT PROVIDED). INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. 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 11 YR Hospitalization| R INSULIN (DATE OF TX: (B)(6))| INSULIN INFUSION SET (DATE OF TX: (B)(6))