BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3421428 · Received October 21, 2013

    Report

    Report Number
    2531779-2013-18329
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Report Date
    October 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/09/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE COVER WAS REMOVED AND THE CONTACT WAS MISSING. ADDITIONALLY, THE CONTRAST KEY CONTACT WAS MISSING. ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE DURING TESTING. THE KEYPAD COVER WAS LIFTING FROM THE PUMP. EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS AND THE UP ARROW, DOWN ARROW, AND OK CONTACTS WERE MISALIGNED. THE CONTRAST KEY CONTACT WAS MISSING. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A UNRESPONSIVE AUDIO BOLUS BUTTON. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/09/2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538900 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR