BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212872 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09946
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 09/20/2013-DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 9/3/2013 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP SHOWED THAT THERE WERE MOISTURE AND CORROSION IN THE DISPLAY WINDOW AND THE INFAR RED PORT WINDOW. THE PUMP FAILED TO STARTUP AND THE PUMP FUNCTIONALITY COULD NOT BE TESTED. WHEN A LEAK TEST WAS PERFORMED, A LEAK WAS FOUND AT THE SEAM BETWEEN THE ¿OK¿ BUTTON AND THE PUMP CASING, AND THE RUBBER KEYPAD WAS PEELING WHERE THE LEAK WAS FOUND. WHEN THE KEYPAD WAS REMOVED, MOISTURE AND CORROSION WERE OBSERVED ON THE BUTTON CONTACTS, CONTAMINATION AND PHYSICAL DAMAGE WERE FOUND UNDER THE BUTTON CONTACTS. REMOVAL OF THE PUMP CASING REVEALED CORROSION AND MOISTURE ON THE SURFACE OF ALL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE HARD TO PRESS AND REQUIRED MULTIPLE, HARD BUTTON PRESSES. REPORTEDLY, THE PUMP HAD BEEN EXPOSED TO WATER WHILE SWIMMING. 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
    313488 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR