BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3160051 · Received June 10, 2013

    Report

    Report Number
    2531779-2013-08010
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 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 DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/05/2013 WITH THE FOLLOWING RESULTS:TESTING CONFIRMED THE CONTRAST AND UP KEYS ARE INTERMITTENTLY RESPONDING TO USER PRESSES AND NEED EXCESSIVE FORCE TO ACTIVATE. REMOVED THE KEYPAD COVER AND FOUND CONTAMINATION UNDER THE UP, DOWN AND OK KEY CONTACTS. UNRELATED TO THE COMPLAINT, A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. REMOVED THE PUMP COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST WITH NO VISIBLE SIGNS OF DISCOLORATION. ALSO UNRELATED,THE BLACK BOX SHOWS THE TIME AND DATE RESETTING TO THE DEFAULT SETTING ON (B)(6) 2013 (11:49->16:02=4HRS 13 MINS.) A VISIBLE INSPECTION SHOWED THE INTERNAL BATTERY WAS LEAKING. 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. (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 BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THE UP/DOWN/OK BUTTONS WERE UNRESPONSIVE AND COULD NOT PASS THE VERIFY SCREEN. 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
    259497 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR