BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1033843 · Received April 24, 2008

    Report

    Report Number
    2531779-2008-00228
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 1, 2007
    Report Date
    March 31, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DAMAGED BATTERY COMPARTMENT CONSISTENT WITH THE PT'S REPORT, BUT DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PT HAD PREVIOUSLY RETURNED THE PUMP DUE TO A DAMAGED BATTERY COMPARTMENT AND REPORTED THAT HE WAS HOSPITALIZED PRIOR TO THE DEVICE BEING RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization