BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2810094 · Received October 31, 2012

    Report

    Report Number
    2531779-2012-12948
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ON INVESTIGATION, THE KEYPAD WAS FOUND TO BE FULLY INTACT WITHOUT PEELING OR VISIBLE DAMAGE. ON TESTING, THE PUMP POWERED ON NORMALLY. ALL THE KEYPAD BUTTONS WERE NORMALLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED EVIDENCE OF MOISTURE CORROSION OF THE PUMP'S INTERIOR TO INCLUDE THE KEYPAD FLEX AND CONNECTOR. A CRACK WAS NOTED IN THE BATTERY COMPARTMENT, ALLOWING MOISTURE LEAKAGE INTO THE BATTERY COMPARTMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS, ALLEGING ALL THE KEYPAD BUTTONS WERE UNRESPONSIVE AFTER WATER EXPOSURE. THE PATIENT DENIED DAMAGE TO THE KEYPAD AND NOTED MOISTURE IN THE BATTERY COMPARTMENT. THE PATIENT REPORTEDLY WORE THE PUMP UNDER A GARMENT, AGAINST THE BODY AND DID NOT CLEAN IT. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR