BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100382 · Received September 18, 2014

    Report

    Report Number
    2531779-2014-26702
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/08/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE PEELING AT THE CONTRAST BUTTON. ALL BUTTON SYMBOLS WERE FOUND TO BE WORN OFF. DURING TESTING, THE DOWN ARROW KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. 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 DOWN ARROW KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. INVESTIGATION ALSO REVEALED THAT THERE WAS CONTAMINATION UNDER ALL KEYPAD BUTTON CONTACTS. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/08/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580673 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR