BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3142714 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07496
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS RETURNED INTACT WITH NO PEELING. THE KEYPAD BUTTON SYMBOLS WERE WORN OFF. DURING TESTING, THE DOWN ARROW AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE; THE UP ARROW AND OK KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING EVALUATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER THE CONTRAST AND DOWN ARROW KEY CONTACTS. ADDITIONALLY, THE PUMP WAS RETURNED WITH A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED AND DISPLAYED PROPERLY. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN AND INTERMITTENTLY UNRESPONSIVE KEYPAD BUTTONS WITH CONTAMINATION FOUND UNDER THE KEY CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245003 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR