BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5765298 · Received July 1, 2016

    Report

    Report Number
    2531779-2016-14329
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Report Date
    June 17, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/17/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS DAMAGE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/17/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420818 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR