BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2150724 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04700
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 8, 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 (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS AND THE UP AND DOWN BUTTON CONTACTS WERE INVERTED. UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE UP AND DOWN ARROW BUTTONS REQUIRED MULTIPLE PRESSES FOR A RESPONSE. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND CLEANED THE PUMP WITH ALCOHOL.

    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 18 YR