BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1083306 · Received July 28, 2008

    Report

    Report Number
    2531779-2008-00424
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED AN EVALUATION OF A CARTRIDGE FROM THE SAME MANUFACTURING LOT AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA. THE PT REPORTED THAT THE PUMP CARTRIDGE WAS CRACKED AND LEAKING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 122 / 1250 / 2020 B201206

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization