BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3855012 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16148
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/23/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION SHOWED THAT THE KEYPAD COVER WAS INTACT AND FREE OF DAMAGE; MOISTURE WAS EVIDENT BEHIND THE DISPLAY LENS. THE PUMP POWERED ON PROPERLY, BUT WITH A BLANK DISPLAY SCREEN. THE FUNCTIONALITY OF THE KEYPAD COULD NOT BE CHECKED DUE TO INTERNAL MOISTURE DAMAGE. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS OBSERVED UNDER THE KEY CONTACTS. A FAILED LEAK TEST REVEALED A LEAK AT THE DISPLAY LENS. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND ON INTERNAL COMPONENTS. UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. ALSO UNRELATED TO THIS COMPLAINT, THE AUDIO BOLUS BUTTON COVER HAD A TEAR IN THE CENTER.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE. IT WAS NOTED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. 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
    335500 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR