BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3243178 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11753
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DIM, DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS USED FOR INVESTIGATION AND WAS FOUND TO FUNCTION PROPERLY. DURING TESTING, NO AUDIO TONES WERE DETECTED. THE VIBRATION MOTOR PINS WERE BROKEN AND WERE FOUND TO NOT BE MAKING AN ELECTRICAL CONNECTION WITH THE PRINTED CIRCUIT BOARD. UNRELATED TO THE DISPLAY AND AUDIBLE TONES ISSUES, EVALUATION REVEALED THAT THE KEYPAD COVER WAS TORN. ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS. ADDITIONALLY, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. 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. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN AND THE PUMP HAD NO AUDIBLE TONES DUE TO BROKEN VIBRATION MOTOR PINS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342826 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR