BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4146227 · Received October 6, 2014

    Report

    Report Number
    2531779-2014-28405
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 09/08/2014 WITH THE FOLLOWING FINDINGS: BATTERY COMPARTMENT CRACKED AND MOISTURE WAS FOUND INSIDE THE BATTERY CAP. (B)(6).

    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 AND MOISTURE IN THE PUMP. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 09/08/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624434 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR