BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050680 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-03986
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 FOLLOW-UP #1 SUBMITTED 05/22/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS:THE OK, UP, DOWN AND CONTRAST KEYS ARE INTERMITTENTLY RESPONSIVE. THE KEYPAD IS INTACT AND WHEN REMOVED FOR INVESTIGATION, CONTAMINATION WAS FOUND UNDER ALL KEYS. UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT THREADS WERE CRACKED AND THE DISPLAY SCREEN HAS A PINKISH FADED CONTRAST WHEN POWERING TO THE VERIFY SCREEN. REMOVED THE PUMP COVER AND REPLACED FADED DISPLAY WITH NEW TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST AND NO SYMPTOMS OF DISCOLORATION OR FADING. 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 A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES AT A CERTAIN ANGLE TO ELICIT A RESPONSE. 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
    148341 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR