BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2599203 · Received June 5, 2012

    Report

    Report Number
    2531779-2012-04868
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    May 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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/STICKING 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 ENGAGE..OBSERVED DAMAGE TO THE KEYPAD-THE KEYPAD COVER IS TORN ACROSS THE 'OK' BUTTON, EXPOSING THE BUTTON CONTACT. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE COMPLAINT, 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. 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 UP DOWN AND OK KEYPAD BUTTONS ARE STICKING AND MUST BE PRESSED HARD SEVERAL TIMES BEFORE RESPONDING. THERE ARE REPORTEDLY NO CRACKS/TEARS IN KEYPAD AND THERE HAS BEEN NO TRAUMA OR WATER EXPOSURE. THE PUMP IS NOT CLEANED AND IS WORN UNDER A GARMENT. 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 45 YR