BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3253986 · Received July 30, 2013

    Report

    Report Number
    2531779-2013-12087
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Report Date
    July 2, 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. 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/24/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/03/2013 WITH THE FOLLOWING FINDINGS: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. NO DAMAGE WAS OBSERVED TO THE PUMP KEYPAD COVER. DURING TESTING, THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE; ALL OTHER KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE UP ARROW, DOWN ARROW, AND CONTRAST KEY CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. WHEN REPLACED WITH A TEST DISPLAY, THE SCREEN FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER INDICATED THAT THE UP ARROW BUTTON REQUIRED MULTIPLE PRESSES TO RESPOND. THE REPORTER DENIED ANY DAMAGE TO THE KEYPAD. 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
    355572 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR