BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213386 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05948
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS ALLEGING THE LABEL ON THE BACK OF THE PUMP WAS PEELING. THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. A VISUAL INSPECTION OF THE DEVICE CONFIRMED THAT THE SERIAL COVER WAS PEELED OFF. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED. THE "OK" BUTTON WAS NOT CLICKING AND SPRINGING BACK DURING TESTING. ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. ALL THE KEY CONTACTS WERE OBSERVED TO BE INVERTED AND WERE NOT ALWAYS SPRINGING BACK. EVIDENCE OF KEYPAD ADHESIVE WAS FOUND UNDER ALL KEY CONTACTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: EVALUATION OF THE PUMP REVEALED THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THERE IS NO EVIDENCE HOWEVER THAT THE REPORTED KEYPAD ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE VALUES, SYMPTOMS, OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    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 14