BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2359629 · Received December 6, 2011

    Report

    Report Number
    2531779-2011-09059
    Event Type
    Malfunction
    Date Received
    December 6, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 11/08/2011 WITH THE FOLLOWING FINDINGS: THE BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE. THE BOLUS BUTTON WAS REMOVED AND THE CONTACT WAS FOUND TO BE UNRESPONSIVE. UNRELATED TO THE EVENT THE CONTRAST BUTTON WAS FOUND TO BE UNRESPONSIVE, THERE WAS CONTAMINATION UNDER THE BUTTON CONTACTS AND THE DISPLAY FLEX WAS FOUND TO BE DAMAGED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN WAS BLANK. THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 11/08/2011 WITH THE FOLLOWING FINDINGS: THE BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE. THE BOLUS BUTTON WAS REMOVED AND THE CONTACT WAS FOUND TO BE UNRESPONSIVE. THIS REPORT IS BEING MADE BASED ON THE RESULTS OF EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR