BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1893614 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-02049
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED NAUSEA AND VOMITING AND A "HIGH" BLOOD GLUCOSE LEVEL. THE PATIENT REPORTED THAT HE WAS TAKEN TO AN EMERGENCY DEPARTMENT AND TAKEN OFF THE PUMP WITH THE DIAGNOSIS OF A HEART ATTACK AND DKA. HIS BLOOD GLUCOSE LEVEL WAS REPORTEDLY 900 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R