BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091853 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03504
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO PRESSES. THE KEYPAD WAS REMOVED AND NO DEFECTS WERE FOUND WITH THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY LENS WAS FOUND TO LEAK; NO EVIDENCE OF MOISTURE WAS OBSERVED INSIDE THE PUMP.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTS PUMP LOCKED UP ON VERIFY SCREEN AFTER EXPOSURE TO POOL WATER AT AMUSEMENT PARK. SHE ALSO REPORTS CONTRAST BUTTON IS WORKING, HOWEVER, UP AND DOWN BUTTONS ARE NOT RESPONDING. PATIENT DOES NOT CLEAN PUMP. PATIENT WEARS PUMP IN POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR