BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3830339 · Received May 23, 2014

    Report

    Report Number
    2531779-2014-14690
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. DURING TESTING, THE PUMP¿S VIBRATORY FEATURE WAS NOT WORKING. THE PUMP WAS OPENED AND EVALUATION REVEALED THAT THE VIBRATION MOTOR HAD FAILED. UNRELATED TO THESE ISSUES, THE KEYPAD SYMBOLS WERE FOUND TO BE WORN AND NO LONGER LEGIBLE, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. EVALUATION ALSO REVEALED THAT THE VIBRATION MOTOR HAD FAILED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307990 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR