BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2041656 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01463
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    February 9, 2011
    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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS; FORCE SENSOR FLEX WAS FOUND TO BE DAMAGED, CAUSING AN INTERMITTENT CONNECTION. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED, WHICH WAS REPRODUCED DURING INVESTIGATION.

    Description of Event or Problem · 1

    PUMP WAS RETURNED TO ANIMAS. PUMP WAS EVALUATED AND FORCE SENSOR PINS WERE FOUND TO BE PARTIALLY DISLODGED AND FORCE SENSOR FLEX WAS FOUND TO BE INTERMITTENT. THIS REPORT IS BEING MADE BASED ON THE EVAL RESULTS.

    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