BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2464403 · Received February 22, 2012

    Report

    Report Number
    2531779-2012-01381
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 25, 2012
    Report Date
    November 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/25/2012 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BOLUS BUTTON IS UNRESPONSIVE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THAT THE BOLUS BUTTON IS UNRESPONSIVE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/25/2012.

    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 60 YR