BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4554508 · Received February 27, 2015

    Report

    Report Number
    2531779-2015-06888
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Report Date
    February 13, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/13/2015 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED. UNRELATED TO THESE ISSUES, THE U-GROOVE ON THE PUMP CASE WAS DAMAGED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 02/13/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138659 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR