BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3203456 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09560
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT 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 DATE OF SUBMISSION 09/11/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/26/2013 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP POWERED ON NORMALLY TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY TONES. THE KEYPAD COVER WAS FOUND TO BE FULLY INTACT WITH NO DAMAGE OR PEELING. THE KEYPAD BUTTONS WERE TESTED AND FOUND TO BE FULLY RESPONSIVE; NO HYPER SENSITIVITY WAS OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS AND NO SELF REWINDING OCCURRED DURING THE EXERCISE. THE PUMP COVER WAS REMOVED, AND NO INTERNAL DAMAGE OR MOISTURE WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE PUMP HAS BEEN REWINDING ON ITS OWN, WITHOUT ANY BUTTONS PRESSES. THE PATIENT STATED THAT THE ISSUE WAS FIRST NOTICED APPROXIMATELY TWO WEEKS AGO. THE PATIENT DENIED ANY DAMAGE TO THE PUMP CASING OR EVIDENCE OF MOISTURE OR CORROSION. NO BUTTON OR KEYPAD ISSUES WERE REPORTED. NO ADVERSE EVENT WAS REPORTED IN ASSOCIATION WITH THIS ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE COULD NOT RESOLVED OR EXPLAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302648 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR