BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212164 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09906
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2013 WITH THE FOLLOWING RESULTS: TESTING FOUND ALL KEYS RESPONSIVE, KEYPAD INTACT, AND NO CONTAMINATION NOTED. NO MOISTURE CORROSION VISIBLE IN ¿BATTERY COMPARTMENT¿. NO LEAKS WAS FOUND DURING TESTING. PUMP COVER WAS REMOVED TO INSPECT INTERNAL COMPONENTS. MOISTURE CORROSION VISIBLE IN PUMP COMPARTMENT. OLED SCREEN IS DISTORTED DUE TO MOISTURE IN PUMP. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING AN ISSUE WITH THE BUTTONS ON THE KEYPAD (TACTILE CHANGES W/MOISTURE). THE REPORTER NOTED THAT THE PATIENT WAS SWIMMING AND THE BUTTONS WERE NONRESPONSIVE. 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
    308711 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR