BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1911912 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02524
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 "UP" ARROW BUTTON WAS INTERMITTENTLY RESPONDING ON THE KEYPAD. THE "UP" ARROW BUTTONS HAD TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. THE REPORTED DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE. THE BUTTON FELT FLAT WHEN PRESSED AND DID NOT CLICK BACK.

    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 19 YR