BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2101528 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03660
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. DURING TESTING, AN EZ-PRIME OPERATION WAS PERFORMED AND THE LOAD STEP DID NOT CORRECTLY DETECT THE CARTRIDGE AND DISPENSED FLUID. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. EVALUATION ALSO REVEALED THAT THE DISPLAY SCREEN WAS DIM WITH A RED TINT.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR SHORT LOAD STEP CAUSING A LARGE PRIME VOLUME. EVALUATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR AND PARTIALLY DISLODGED FORCE SENSOR PINS. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29