BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2598385 · Received June 5, 2012

    Report

    Report Number
    2531779-2012-04849
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    May 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 'DOWN' AND 'OK' BUTTONS WILL ENGAGE. CONFIRMED THE 'OK' AND 'DOWN' BUTTONS ARE STICKING AND ARE HYPER-RESPONSIVE/SCROLLING IN RESPONSE TO BUTTON PRESSES. NO VISIBLE DAMAGE ON THE KEYPAD. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS..CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS..UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED AT OPENING OF BATTERY CHAMBER EXTENDING DOWN BENEATH THE FINGER PAD EXTENDING TO THE PRIMARY SEAL AND THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED. (B)(4). 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. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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) 2012,THE REPORTER CALLED ANIMAS ALLEGING THAT THE OK BUTTON AND THE DOWN ARROW WERE FAILING TO RESPOND WHEN PUSHED. REPORTER STATES THAT THE RUBBER IS INTACT, NO RIPS OR TEARS, AND THAT THE SYMBOLS ARE PRESENT. BOLUSES ARE BEING CANCELLED (INTERMITTENTLY) AND SCREENS SKIP THROUGH. THIS IS HAS BEEN HAPPENING FOR SEVERAL MONTHS. THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD MALFUNCTION REMAINED UNRESOLVED.

    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 18 YR