BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2101591 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03662
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION, AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. DURING INVESTIGATION, THE LOAD STEP WAS PERFORMED AND THE PUMP DID NOT DETECT THE CARTRIDGE, WHICH RESULTED IN ALL OF THE FLUID BEING DISPENSED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXCESSIVE PRIME VOLUME. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THIS REPORT IS BEING MADE BASED ON EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR