BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3994161 · Received August 8, 2014

    Report

    Report Number
    2531779-2014-22839
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/31/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE THREADS WERE DAMAGED. THE BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP. THE BATTERY CAP THREADS WERE STRIPPED AND THE ¿COIN SLOT¿ WAS DAMAGED. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT AND BATTERY CAP WERE DAMAGED. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/31/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467987 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR