BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2942445 · Received February 4, 2013

    Report

    Report Number
    2531779-2013-01472
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THERE WAS NO PUMP KEYPAD DAMAGE. THE CONTRAST BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES; THE CONTRAST BUTTON HAS NO EFFECT ON THE PUMP'S INSULIN DELIVERY FUNCTION. ALL OTHER KEYPAD BUTTONS WERE TESTED AND WERE FOUND TO BE RESPONDING NORMALLY. THE KEYPAD WAS REMOVED FROM THE PUMP AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, MOISTURE WAS FOUND IN THE BATTERY COMPARTMENT. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR WORN BUTTON SYMBOLS. DURING INVESTIGATION, CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46560 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR