BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3042260 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03832
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: DURING INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, THE BLACK BOX HISTORY WAS REVIEWED AND REVEALED THE TIME AND DATE HAD RESET WITHIN 12 MINUTES OF POWER OFF. DURING TESTING, THE PUMP TIME AND DATE RESET TO THE DEFAULT SETTINGS. THE PUMP WAS OPENED TO INVESTIGATE AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING. 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 A DIM AND DISCOLORED DISPLAY SCREEN. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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
    145828 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR