BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1802549 · Received August 9, 2010

    Report

    Report Number
    2531779-2010-00880
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. PUMP SETTINGS AND DELIVERY HISTORY WERE REVIEWED WITH THE PT 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 LOW BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization