BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222894 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10455
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2013 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, THE KEYPAD COVER WAS OBSERVED TO BE INTACT WITH NO PEELING OR TEARING. DURING TESTING, ALL THE KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THE KEYPAD COVER WAS OPENED AND NO ISSUES WERE FOUND. UNRELATED TO THE COMPLAINT, A HOLE WAS FOUND IN THE AUDIO BOLUS BUTTON COVER; THE BUTTON WAS FUNCTIONAL DURING TESTING. A LEAK TEST WAS PERFORMED AND A BOLUS BUTTON LEAK WAS FOUND. NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND. 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.

    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. THIS

    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 INTERMITTENTLY UNRESPONSIVE. THE REPORTER STATED THE PUMP'S 'UP', 'DOWN', AND OK BUTTONS HAVE BEEN WORKING INTERMITTENTLY FOR THE PAST 2 MONTHS. THE BUTTONS ARE NOW NO LONGER WORKING SINCE THE PATIENT JUMPED INTO A POOL AFTER UNRESPONSIVENESS WAS NOTED. THE REPORTER STATED THERE IS NO EVIDENCE OF MOISTURE IN 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
    321869 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR