BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221738 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10352
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/23/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, NO MOISTURE WAS OBSERVED BEHIND THE DISPLAY LENS. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND DUE TO A CRACKED PUMP CASE. THE PUMP CASE WAS OPENED AND MOISTURE WAS FOUND THROUGHOUT THE PUMP COMPARTMENT. THE KEYPAD SYMBOLS WERE WORN, BUT THE KEYPAD COVER WAS INTACT. DURING TESTING, THE CONTRAST AND UP ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE; ALL OTHER KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT UP, DOWN, AND OK BUTTONS WERE INTERMITTENTLY UNRESPONSIVE FOR A COUPLE OF MONTHS AND HAVE WORN SYMBOLS. THE REPORTER STATED THAT THERE WAS MOISTURE BEHIND THE LENS. 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
    319652 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR