BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241945 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11655
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/08/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/19/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD IS TORN FROM THE UP TO THE OK KEYPAD SYMBOLS. THE CONTRAST BUTTON HAS AN INTERMITTENT RESPONSE. THE UP, DOWN, & OK BUTTONS RESPOND PROPERLY. CONTAMINATION WAS FOUND UNDER THE CONTRAST AND DOWN BUTTONS WHEN THE KEYPAD WAS REMOVED. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT WHEN BOOTED TO THE VERIFY SCREEN, THE PUMP HAD A DIM PINK CONTRAST. THE PUMP COVER WAS REMOVED AND THE OLED SCREEN WAS REMOVED AND REPLACED WITH A NEW TEST SCREEN. ONCE COMPLETED, THE CONTRAST RETURNED TO NORMAL.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. IT WAS REPORTED THAT THERE WAS A TEAR FROM TOP OF UP ARROW TO THE OK BUTTON, ALONG WITH UNRESPONSIVENESS OF BUTTONS FOR A COUPLE HOURS SEVERAL WEEKS AGO. 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
    340183 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR