BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1031260 · Received April 18, 2008

    Report

    Report Number
    2531779-2008-00216
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DAMAGED FORCE SENSOR BUT DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED EMERGENCY ROOM TREATMENT FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA. THE PATIENT REPORTED THAT THE PUMP WAS EMITTING OCCLUSION ALARMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization