BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082681 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05500
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD IS INTACT BUT THE OK AND UP KEYPAD SYMBOLS WERE WORN. THE UP AND DOWN KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND THE CONTRAST AND OK BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THAT CONTAMINATION WAS FOUND UNDER THE CONTRAST, UP AND DOWN KEY CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. PUMP COVER WAS REMOVED AND THE OLD SCREEN WAS REMOVED AND REPLACED WITH A NEW TEST SCREEN, CONTRAST RETURNED TO NORMAL WITH TEST SCREEN. A VISUAL INSPECTION OF "BATTERY COMPARTMENT¿ REVEALED, COMPARTMENT CRACK AT THREADS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE DOWN ARROW BUTTON WAS STICKING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183902 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR