BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4171664 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29174
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/01/2014 WITH THE FOLLOWING FINDINGS:EVALUATION REVEALED THAT THE DISPLAY IS DIM AND PINK. THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO DAMAGE OR PEELING TO KEYPAD. THE CONTRAST KEY IS INTERMITTENTLY UNRESPONSIVE. THE OK, DOWN AND UP KEYS RESPOND APPROPRIATELY. EVALUATION REVEALED THAT THERE WAS CONTAMINATION UNDER THE CNTRAST KEY CONTACT. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(4)

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE DISPLAY WAS DIM AND PINK, THE BATTERY COMPARTMENT WAS CRACKED AND CONTAMINATION WAS FOUND UNDER KEY CONTACT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/01/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650083 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR