BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3925626 · Received July 10, 2014

    Report

    Report Number
    2531779-2014-19527
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 06/30/2014 WITH THE FOLLOWING FINDINGS: UNABLE TO VERIFY A TIME/DATE RESET TO THE DEFAULT SETTING IN THE BLACK BOX; BENCH TOP ANALYSIS CONFIRMED WHEN THE FULLY CHARGED BATTERY WAS REINSERTED AFTER 6HRS WITHOUT POWER THE TIME AND DATE RESET TO 12:00AM 1/1/2007. INSPECTION CONFIRMED THE INTERNAL BATTERY WAS LEAKING AND THE BATTERY COMPARTMENT IS CRACKED AT THE CASE SEAL.

    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 LEAKING INTERNAL BATTERY AND A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 06/30 /2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405112 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR