BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2020583 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00498
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 1, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PUMP'S BATTERY LIFE WAS SHORT AND THE PUMP WAS WARM TO THE TOUCH. SHE DENIED THAT THE PUMP CAUSED ANY BURNS OR HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR