BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3532704 · Received December 23, 2013

    Report

    Report Number
    2531779-2013-24942
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Report Date
    December 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2013 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. ON INVESTIGATION THE PUMP POWERED UP TO A DIM AND DISCOLORED VERIFY SCREEN WITH APPROPRIATE AUDIO/VIBRATION ALERTS. UNRELATED TO THE DISPLAY ISSUE A WORN BAR CODE WAS OBSERVED ON THE PUMP LABEL. NO OTHER DEFECTS WERE FOUND. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/09/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673695 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR