BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2850349 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14047
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2012 STATING THAT THE DOWN ARROW KEYPAD BUTTON REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE REPORTER DENIED ANY DAMAGE TO THE PUMP OR ANY EVIDENCE OF MOISTURE IN THE PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4): THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, THE KEYPAD WAS REMOVED AND NO CONTAMINATION OR DAMAGE WAS FOUND. 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE DOWN ARROW KEYPAD BUTTON REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE REPORTER DENIED ANY DAMAGE TO THE PUMP OR ANY EVIDENCE OF MOISTURE IN THE PUMP. THE PUMP WAS REPORTEDLY CLEANED WITH ALCOHOL WIPES AND THE PATIENT REPORTEDLY WORE THE PUMP ON A BELT. THERE IS NO ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUES

    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 10 YR