BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2120326 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01553
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 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

    THE 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 NOT BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED AND TREATED FOR KETOSIS IN THE INTENSIVE CARE UNIT FROM (B)(6) 2011 AND WAS THEN TRANSFERRED TO THE REGULAR CARE UNIT (B)(6) 2011. THE REASON FOR HOSPITALIZATION WAS A KINKED INFUSION SET CANNULA (COMPETITOR PRODUCT). THE PT'S MOTHER REPORTED THE INFUSION DEVICE DID NOT PROPERLY DISPLAY W1 (CARTRIDGE LOW) WARNING OR E4 (OCCLUSION) ERROR. NO FURTHER INFO IS AVAILABLE. 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 11 YR Hospitalization| R INSULIN: (DATE OF TX (B)(6))| INSULIN INFUSION DEVICE:| (DATE OF TX (B)(6))