BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822334 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14225
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/13/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTED TO THE VERIFY SCREEN WITH A DIM AND DISCOLORED CONTRAST. THERE WAS A CRACK ALONG THE BATTERY COMPARTMENT. UNRELATED TO THE ISSUE, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED AND THERE WAS A CRACK IN THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/13/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298766 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR