BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4132859 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28021
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/24/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE PEELING FROM THE BOTTOM TOWARDS THE TOP. CONTAMINATION WAS NOTED UNDERNEATH THE UP ARROW, DOWN ARROW, OKAY, AND CONTRAST BUTTON CONTACTS. THE PUMP BOOTED ON WITH A BLANK DISPLAY BUT AUDIO AND VIBRATORY SIGNALS WERE PRESENT. THE PUMP FAILED A LEAK TEST DUE TO THE KEYPAD COMING LOOSE FROM THE PUMP. INVESTIGATORS WERE UNABLE TO TEST OR CONFIRM THE KEYPAD RESPONSIVENESS DUE TO THE BLANK DISPLAY THAT RESULTED FROM THE MOISTURE DAMAGE.

    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 CNGS PRIOR DMG W/MOIST) ISSUE. 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
    612779 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR