BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1812049 · Received August 18, 2010

    Report

    Report Number
    2531779-2010-01043
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INSULIN DELIVERY SETTINGS WERE REVIEWED WITH THE PT AND CONFIRMED AS CORRECT. 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. THE PT ALSO REPORTED THAT THE PUMP DID NOT RECORD BOLUS INSULIN DOSES IN THE HISTORY ALTHOUGH DOSES WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization