BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5378499 · Received January 19, 2016

    Report

    Report Number
    2531779-2016-02018
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Report Date
    January 5, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/05/2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK. THE BOLUS BUTTON COVER WAS TORN; THE BOLUS BUTTON WAS APPROPRIATELY RESPONSIVE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 01/05/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34582 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR