BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2198561 · Received August 10, 2011

    Report

    Report Number
    2531779-2011-05738
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    May 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/13/2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION, AND A DAMAGED FORCE SENSOR PLATE WAS OBSERVED. UNRELATED TO THE KEYPAD COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR INVESTIGATION. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION, AND A DAMAGED FORCE SENSOR PLATE WAS OBSERVED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/13/2011.

    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 65 YR