BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3786408 · Received May 2, 2014

    Report

    Report Number
    2531779-2014-12286
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/22/2014 WITH THE FOLLOWING FINDINGS:DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DISCOLORED. UNRELATED TO THESE ISSUES, TESTING REVEALED THE TIME AND DATE RESET TO FACTORY SETTINGS. THE PUMP CASE WAS REMOVED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE CIRCUIT BOARD HAD FAILED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK AND A DISPLAY FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04/22/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265947 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR