BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050521 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-03971
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/14/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THERE WAS A DIM PINK/FADED DISPLAY SCREEN. THE PUMP WAS OPENED TO REMOVE DISPLAY SCREEN. EVALUATION WAS COMPLETED WITH A TEST DISPLAY SCREEN, THE DISPLAY SCREEN IS SHOWING A STRONG CONTRAST. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON 02/12/2013 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN BOOTED WITH A DIM, PINK/FADED DISPLAY. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148555 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1