BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2212235 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05893
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED CONTAMINATION UNDER KEYPAD BUTTON CONTACTS. THE BUTTONS INTERMITTENTLY ACTIVATED PUMP FUNCTIONS WHEN PRESSED. UNRELATED TO THE COMPLAINT, THE CHARACTERS ON THE DISPLAY SCREEN WERE DIM AND REDDISH. 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 THE PUMP BUTTONS HAVE NOT ACTIVATED DESIRED PUMP FUNCTIONS AS EXPECTED FOR THE PAST FOUR MONTHS. SHE SAYS, SHE CLEANS THE PUMP WITH ALCOHOL. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 YR