BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942340 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-03055
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING EVAL THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. EVAL REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    DURING EVAL THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR PINS WERE FOUND TO BE PARTIALLY DISLODGED.

    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 36 YR