BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913804 · Received November 26, 2010

    Report

    Report Number
    2531779-2010-02572
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECS AT THE TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY DID NOT INDICATE THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. DURING EVAL, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. INTERNAL MOISTURE DAMAGE WAS OBSERVED ON THE PRINTED CIRCUIT BOARD ASSEMBLY, THE VIBRATE MOTOR, AND THE FORCE SENSOR HOUSING.

    Description of Event or Problem · 1

    DURING EVAL, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    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 17 YR