BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1882867 · Received October 22, 2010

    Report

    Report Number
    2531779-2010-01786
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE KEYPAD IS NOT RESPONDING APPROPRIATELY. HE REPORTS THAT THE 'DOWN' AND 'OK' BUTTONS ARE INTERMITTENTLY UNRESPONSIVE, AND HE MUST PRESS THE BUTTONS MULTIPLE TIMES TO GET A RESPONSE. NO UNUSUAL ACTIVITY WITH THE PUMP AND HE DOES NOT EXPOSE THE PUMP TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR