BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3585728 · Received January 21, 2014

    Report

    Report Number
    2531779-2014-02199
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Report Date
    January 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/09/2014 WITH THE FOLLOWING FINDINGS: THE UP, DOWN AND OK KEYPAD SYMBOLS ARE WORN. THE DISPLAY IS DIM AND REDDISH. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY IS DIM AND REDDISH. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/09/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47928 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR