BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4123176 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27703
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 17, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP; ALL TESTING WAS PERFORMED WITH A TEST BATTERY CAP WHICH WAS UNABLE TO BE FULLY TIGHTENED. THE BATTERY COMPARTMENT THREADS WERE OBSERVED TO BE DAMAGED. THERE WAS NO LOSS OF POWER OBSERVED WITH THE TEST BATTERY CAP AND THE PUMP POWERED ON TO A DIM, DISCOLORED DISPLAY. THE BLACK BOX SHOWED NO OCCURRENCES OF THE TIME/DATE DEFAULTING. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP MAINTAINED THE TIME/DATE ACCURATELY DURING A 5 DAY DURATION TEST, HOWEVER, WHEN THE PUMP WAS LEFT WITHOUT POWER FOR 1 HOUR, THE PUMP DEFAULTED TO FACTORY SETTINGS. THE PUMP COVER WAS REMOVED FOR FURTHER INVESTIGATION AND VISIBLE INSPECTION CONFIRMED AN INTERNAL CLOCK BATTERY MALFUNCTION.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM DISPLAY, STRIPPED THREADS IN THE BATTERY COMPARTMENT AND A MISSING BATTERY CAP. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602917 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR