BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2599062 · Received June 5, 2012

    Report

    Report Number
    2531779-2012-04855
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    May 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'UP', 'DOWN', 'OK' AND 'CONTRAST' BUTTONS. MULTIPLE BUTTON PRESSES WITH INCREASED FORCE APPLIED ARE REQUIRED BEFORE THE 'UP', 'DOWN', 'OK' AND 'CONTRAST' BUTTONS WILL ENGAGE..CONFIRMED THE 'UP', 'DOWN' AND 'OK' BUTTONS ARE STICKING AND ARE HYPER-RESPONSIVE/SCROLLING IN RESPONSE TO BUTTON PRESSES..CONFIRMED DAMAGE TO THE KEYPAD-THE KEYPAD COVER IS PEELING BELOW THE 'OK' BUTTON, AND IS TORN OFF AT THE 'UP', 'DOWN' AND 'OK' BUTTONS, EXPOSING THE BUTTON CONTACTS. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE DISPLAY, THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION IS NOT COMPLETE. ONCE EVALUATION IS COMPLETE A SUPPLEMENTAL WILL BE SUBMITTED. 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 CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE ARROWS AND OK BUTTONS REQUIRED SEVERAL PRESSES TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATE WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR