BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5777585 · Received July 7, 2016

    Report

    Report Number
    2531779-2016-15085
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Report Date
    June 24, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/24/2016 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE DISPLAY SCREEN WAS DIM AND DISCOLORED. UNRELATED TO THESE ISSUES, THE PUMP CASING WAS CRACKED AROUND THE DISPLAY, AND THE KEYPAD WAS PEELING. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/24/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431483 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR