BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191275 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09053
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 28, 2013
    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 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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 08/21/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING RESULTS: PUMP CASE CRACKED IN UPPER RIGHT HAND CORNER OF THE DISPLAY AREA. LEAK TEST SHOWS LEAK AT CRACK IN PUMP CASE. PUMP CASE WAS REMOVED, EVIDENCE OF MOISTURE DAMAGE WAS IDENTIFIED INSIDE PUMP, ON DISPLAY FLEX CABLE AND CONNECTOR AND ON MISCELLANEOUS ELECTRICAL COMPONENTS. PUMP POWERS WITN AN AUDIBLE TONE, VIBRATION AND A BLANK DISPLAY BUT IS UNRESPONSIVE DUE TO INTERNAL MOISTURE DAMAGE. UNABLE TO COMPLETE ALL TESTING STEPS. MOISTURE EVIDENT BEHIND DISPLAY LENS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THE PUMP IS NO LONGER WORKING AND THERE WAS NO POWER TO THE PUMP. THERE WAS REPORTEDLY A HOLE ABOVE THE UP ARROW KEYPAD BUTTON AND WATER WAS IN THE PUMP. THE PATIENT REPORTEDLY WAS ON AN ALTERNATE BACK-UP PLAN FOR INSULIN DELIVERY. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291496 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR