BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3252891 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12029
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 TESTING, THE DISPLAY SCREEN WAS FOUND TO BE DIM/ DISCOLORED. A TEST SCREEN WAS INSERTED AND FUNCTIONED APPROPRIATELY. UNRELATED TO THE DISPLAY ISSUE, THE PUMP HISTORY AND TESTING CONFIRMED THE PUMP¿S TIME AND DATE RESET TO FACTORY SETTINGS WHEN THE BATTERY WAS REMOVED. THE PUMP WAS OPENED 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. (B)(4).

    Description of Event or Problem · 1

    THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM/FADED. 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
    353544 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR