BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMAS INSULIN INFUSION PUMP

    MDR report key: 1893673 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-01985
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE OK AND UP/DOWN ARROW BUTTONS WERE INTERMITTENTLY UNRESPONSIVE ON KEYPAD. THE BUTTONS NO LONGER SPRING BACK AND CLICK. THE REPORTER DENIES EXPOSURE TO MOISTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR