BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1760090 · Received July 9, 2010

    Report

    Report Number
    2531779-2010-00608
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 11, 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

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL DEMONSTRATED THAT THE PUMP OPERATED WITHIN REQUIRED SPECIFICATIONS AND WAS DELIVERING INSULIN ACCURATELY. THE PUMP WAS EXERCISED AND WAS NOT FOUND TO OVERHEAT. THE BATTERY RETURNED WITH THE PUMP ALSO SHOWED NO EVIDENCE OF OVERHEATING. A DEVICE HISTORY RECORD FOR THE REPORTED PUMP WAS REVIEWED, AND THERE WAS NO EVIDENCE OF ANY DEFECTS AFTER THE PUMP WAS MANUFACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP EMITTED A "REPLACE BATTERY" ALARM AT WHICH TIME THE PUMP CASING WAS FOUND TO BE HOT TO THE TOUCH. THE PUMP CASING REPORTEDLY RETURNED TO NORMAL TEMPERATURE WITHIN TEN MINUTES.

    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 15 YR