BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2200977 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05786
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/04/2011 WITH THE FOLLOWING FINDINGS: THE DOWN ARROW BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES AND REQUIRED INCREASED FORCE FOR THE BUTTON TO ENGAGE. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED AND THE DISPLAY LENS WAS DETACHED FROM THE PUMP. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT FOR TWO WEEKS THE DOWN ARROW BUTTON REQUIRED MULTIPLE HARD PRESSES TO ELICIT A RESPONSE. THE PATIENT CONFIRMED THAT THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP IN AN UNDERGARMENT, OCCASIONALLY USING A PUMP CASE, 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 24 YR