BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3133234 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07150
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP DISPLAY SCREEN WAS FOUND TO HAVE VERTICAL LINES THROUGH THE LETTERING. THE PUMP WAS OPENED AND THE DISPLAY SCREEN WAS RESEATED WITHOUT RESOLVING THE LINES THROUGH THE DISPLAY. THE PUMP DISPLAY WAS REPLACED WITH A TEST DISPLAY AND THE ISSUE RESOLVED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. THE INVESTIGATION REVEALED A FAILED DISPLAY FLEX. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236944 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR