BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1882525 · Received October 21, 2010

    Report

    Report Number
    2531779-2010-01777
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY SCREEN FLASHED CS AND THEN LOST POWER. A FAMILY MEMBER REPORTED THAT THE BATTERY CAP WAS SECURE AND INTACT, DENIED THERE WERE CRACKS IN THE CASE, AND NOTED THAT THE BATTERY COMPARTMENT WAS DRY. IT WAS REPORTED THAT REPLACING THE BATTERY AND THE BATTERY CAP DID NOT RESTORE POWER. THE FAMILY MEMBER STATED THAT HE SHOOK THE PUMP, THE POWER CAME ON AS EVIDENCED BY AUDIBLE TONE, AND THE DISPLAY SCREEN WAS FROZEN ON THE VERIFICATION SCREEN.

    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 9 YR