BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210934 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09803
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/7/2013 WITH THE FOLLOWING FINDINGS: THE PAINT CASE IS PEELING. THE KEYPAD SYMBOLS ARE WORN; THERE WAS NO PEELING OR DAMAGE OBSERVED. DURING TESTING, THE UP BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE DOWN, OK, AND CONTRAST BUTTONS RESPOND PROPERLY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS REPORTING A BUTTON/KEYPAD TACTILE CHANGES/UNRESPONSIVE ISSUE. THE REPORTER STATED THAT THE UP, DOWN, AND OK BUTTONS WERE NOT RESPONDING AS THEY SHOULD AND THE PATIENT HAD TO PRESS THE BUTTONS MULTIPLE TIMES TO RESPOND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310417 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR