BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3844398 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15505
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/30/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/25/2014 WITH THE FOLLOWING FINDINGS:DURING A VISUAL INSPECTION OF THE PUMP, NO DAMAGE WAS FOUND TO THE KEYPAD COVER. DURING TESTING, THE DOWN ARROW KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE; ALL OTHER KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED, AND CONTAMINATION WAS FOUND UNDER THE DOWN ARROW AND CONTRAST BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE UNDER RESPONSIVE. 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
    321359 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR