BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3171851 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08270
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/15/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: KEYPAD BUTTON COVER AND BOLUS BUTTON WERE FOUND TO BE INTACT. THE KEYPAD BUTTONS AND THE AUDIO BOLUS BUTTON WERE FOUND TO BE UNRESPONSIVE. THE KEYPAD BUTTON FLEX WAS FOUND TO BE CORRODED. THE PUMP CASE WAS OPENED; MOISTURE AND CORROSION WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, MOISTURE WAS FOUND IN THE DISPLAY SCREEN. THE PUMP DISPLAY WAS UNABLE TO BE READ; LINES AND DOTES WERE NOTED ON THE PUMP DISPLAY SCREEN. THE PUMP POWERED ON WITH THE APPROPRIATE AUDIBLE AND VIBRATORY ALARMS. THE BLACK BOX HISTORY WAS UNABLE TO BE DOWNLOADED DUE TO MOISTURE ISSUE. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. REPORTEDLY, THE PATIENT WENT SWIMMING WITH THE PUMP AND RECEIVED AN ALARM; THE PUMP WAS REBOOTED AND THE OK BUTTON WAS FOUND TO BE UNRESPONSIVE. MOISTURE WAS NOTED BEHIND THE DISPLAY 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
    273570 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR