BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221044 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10320
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/13/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT MOISTURE CAN BE SEEN FROM BEHIND THE DISPLAY LENS. PERFORMED THE LEAK TEST AND FOUND A LEAK DUE TO A CRACKED PUMP CASE. OPENED THE PUMP CASE AND FOUND MOISTURE THROUGHOUT THE PUMP. THERE'S NO VISIBLE DAMAGE TO THE KEYPAD. ALL OF THE KEYPAD BUTTONS RESPOND PROPERLY. REMOVED THE KEYPAD AND FOUND NO DAMAGE OR CONTAMINATION TO THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER INDICATED THAT THE UP AND DOWN ARROW BUTTONS WERE COMPLETELY UNRESPONSIVE TO PRESSES. THE REPORTER STATED THAT THERE WAS NO INDICATION OF DAMAGE TO THE KEYPAD BUT NOTED THAT THERE WAS MOISTURE BEHIND THE DISPLAY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320900 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR