BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3090531 · Received May 2, 2013

    Report

    Report Number
    2531779-2013-05815
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 07/11/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 06/13/2013 WITH THE FOLLOWING RESULTS: PUMP RETURNED WITH THE AUDIO BOLUS BUTTON COVER DETACHED FROM THE PUMP. UNABLE TO TEST THE AUDIO BOLUS BUTTON DUE TO THE MISSING COVER.THE UP, DOWN, OK AND CONTRAST KEYS ARE RESPONSIVE TO USER PRESSES.. REMOVED THE KEYPAD COVER; CONTAMINATION WAS PRESENT UNDER THE UP, OK, DOWN AND CONTRAST KEY CONTACTS. UNRELATED TO THIS 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. 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 (BUTTON/KEYPAD ISSUE) ISSUE. THE REPORTER STATED THE AUDIO BOLUS BUTTON IS "LOOSE." 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
    193059 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR