BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100354 · Received September 18, 2014

    Report

    Report Number
    2531779-2014-26710
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, THE DISPLAY LENS WAS FOUND TO BE CRACKED. DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. UNRELATED TO THESE DISPLAY ISSUES, THE INFORMATION LABEL ON THE BACK OF THE PUMP WAS MISSING. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED DISPLAY LENS AND A DISPLAY FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/05/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580075 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR