BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3940805 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20399
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2014 WITH THE FOLLOWING FINDINGS: INVESTIGATORS PERFORMED REWIND, LOAD, AND PRIME NO ALARMS. INVESTIGATORS INSPECTED LEAD SCREW AND MOTOR DRIVE ASSEMBLY AND THERE WAS NO DEFECT FOUND. THE DISPLAY WAS FADED AND PINK. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE DISPLAY WAS FADED AND PINK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/08/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418331 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR