BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1810083 · Received August 16, 2010

    Report

    Report Number
    2531779-2010-00917
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 17, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO ANIMAS. IF THE PUMP IS RETURNED, AN EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. PUMP SETTINGS AND INSULIN DELIVERY HISTORY WERE REVIEWED WITH THE DOCTOR AND CONFIRMED AS ACCURATE. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization