BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3854937 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16104
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 05/23/2014 WITH THE FOLLOWING FINDINGS: NO POWER ON RESET EVENTS WERE RECORDING IN THE BLACK BOX TO SUPPORT TIME AND DATE RESETS. PUMP WAS EXERCISED FOR 24 HOURS, THEN BATTERY WAS REMOVED FOR 6 HOURS, AND THE TIME AND DATE RESET TO DEFAULT SETTINGS. PUMP WAS OPEN TO INVESTIGATE AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING AND UNABLE TO HOLD A CHARGE. UNRELATED TO THE COMPLAINT, THERE IS A CRACK IN THE BATTERY COMPARTMENT AND THE DISPLAY IS DIM AND PINK. 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

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A LEAKING INTERNAL BATTERY, A DIM PINK DISPLAY AND A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 05/23/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336547 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR