BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213251 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05942
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): TESTING CONFIRMED THE DOWN BUTTON IS UNRESPONSIVE. THE KEYPAD WAS TORN AND WAS REMOVED FOR INVESTIGATION. CONTAMINATION WAS FOUND UNDER ALL BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DOWN ARROW BUTTON STOPPED RESPONDING. THE PATIENT CONFIRMED THERE WERE NO HOLES OR TEARS IN THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP ON THE OUTSIDE OF CLOTHING AND DID NOT CLEAN THE PUMP.

    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 40 YR