BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3231286 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11070
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/10/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED 3 UNEXPLAINED POWER EVENTS. THERE WAS NO MOISTURE OR CORROSION VISIBLE IN THE DISPLAY LENS OR IN THE BATTERY COMPARTMENT. THERE WERE NO CRACKS FOUND IN THE PUMP CASING. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR TESTING. A TEST BATTERY CAP WAS INSERTED AND THE PUMP POWERED ON APPROPRIATELY. THE PUMP WAS UNABLE TO BE EXERCISED DUE TO UNRESPONSIVE KEYPAD BUTTONS. A LEAK TEST WAS PERFORMED ON THE PUMP AND NO LEAKS WERE FOUND. THE PUMP CASE WAS OPENED AND NO MOISTURE OF CORROSION WAS OBSERVED INSIDE THE PUMP. THE KEYPAD WAS EXAMINED RELATED TO THE UNRESPONSIVE ISSUE. THE KEYPAD WAS FOUND TO BE TORN AT THE UP BUTTON. THE CONTRAST, UP, AND DOWN BUTTONS WERE FOUND TO BE UNRESPONSIVE. THE KEYPAD WAS REMOVED AND CORROSION WAS FOUND UNDER THE CONTRAST, UP, AND DOWN BUTTON CONTACTS AND ON THE BUTTON TRACES. THE ALLEGED PUMP POWER ISSUE WAS UNABLE TO BE FULLY INVESTIGATED DUE TO THE KEYPAD ISSUE. THE USER GUIDE INSTRUCTS THE PATIENT THAT DAMAGE TO THE PUMP MAY IMPACT THE WATERPROOF FEATURE OF THE PUMP. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER INDICATED THAT THE PUMP LOST POWER AFTER GOING IN THE WATER. THE REPORTER INDICATED THAT THERE WAS NO DAMAGE TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332288 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR