BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3041008 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03787
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 06/13/2013DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD IS INTACT. ON TESTING, ALL THE KEYPAD BUTTONS WERE RESPONSIVE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE BUTTONS. THE DISPLAY LENS WAS NOTED TO BE CRACKED AROUND THE EDGES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS REQUIRED HARD PRESSES TO ELICIT A RESPONSE. THE REPORTER NOTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTON SYMBOLS WERE WORN OFF. 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
    142710 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR