BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3832373 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14812
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 21, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: PUMP WAS EXERCISED FOR 24 HOURS; BATTERY WAS REMOVED FOR 6 HOURS AND THE TIME AND DATE RESET TO DEFAULT. THERE'S A CRACK ALONG THE BATTERY COMPARTMENT THREADS. PUMP WAS OPENED TO INVESTIGATE AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING AND UNABLE TO HOLD A CHARGE. PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. 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 CRACKED BATTERY COMPARTMENT, LEAKING INTERNAL BATTERY, AND DIM PINK DISPLAY. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311607 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR