BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221128 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31257
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/04/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE FULLY INTACT; NO PEELING WAS OBSERVED. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE UP ARROW, DOWN ARROW, AND CONTRAST KEY CONTACTS. THE FUNCTIONALITY OF THE KEYPAD WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE DISPLAY BEING DIM AND UNREADABLE. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. AN ATTEMPT TO CONTACT THE PATIENT HAS BEEN MADE. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AVAILABLE AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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
    702421 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR