BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2211494 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05876
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    September 9, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. SHE STATED THAT THE PATIENT WORE THE PUMP IN HER POCKET; DENIED PHYSICAL DAMAGE TO THE KEYPAD; AND DENIED EXPOSING THE PUMP TO WATER.

    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 15 YR