BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3915495 · Received July 7, 2014

    Report

    Report Number
    2531779-2014-19196
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/04/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE CUT AND TORN. EVALUATION REVEALED THAT THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND ON THE KEYPAD TRACES. ALSO, THE KEYPAD FLEX WAS OBSERVED TO BE DAMAGED. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND ON INTERNAL KEYPAD COMPONENTS. UNRELATED TO THIS COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. ALSO UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (DMG PRIOR TACTILE CNGS W/MOIST) ISSUE. IT WAS REPORTED THAT THE DOWN ARROW KEYPAD BUTTON WAS UNDER RESPONSIVE TO USER PRESSES. MOISTURE WAS ALLEGEDLY VISIBLE IN THE KEYPAD AREA OF THE PUMP, AND THE KEYPAD COVER WAS DAMAGED. 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
    394399 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR