BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4642521 · Received March 30, 2015

    Report

    Report Number
    2531779-2015-10425
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Report Date
    March 18, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 03/18/2015 WITH THE FOLLOWING FINDINGS: THE TOP OF THE RETURNED BATTERY CAP WAS OBSERVED TO BE WORN. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DAMAGED BATTERY CAP. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/18/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208083 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR