BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3140131 · Received May 31, 2013

    Report

    Report Number
    2531779-2013-07439
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/03/2013 WITH THE FOLLOWING RESULTS: TESTING FOUND AN AUDIO BOLUS BUTTON LEAK FOUND DURING THE LEAK TEST. REMOVED THE PUMP COVER; INTERNAL MOISTURE OBSERVED IN THE PUMP. PUMP POWERS ON TO THE DISPLAY SCREEN WITH VIBRATORY AND AUDIBLE SOUNDS. DISPLAY SCREEN HAS NORMAL CONTRAST. AUDIO BOLUS BUTTON LEAK FOUND DURING. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE PUMP EMITTED A CALL SERVICE ALARM AND THEN THE DISPLAY SCREEN WENT BLANK AND THE PUMP WAS VIBRATING AND THE PUMP HAD STOPPED DELIVERING. REMOVING THE BATTERY AND REINSERTING IT SUCCESSFULLY POWERED THE PUMP BACK ON AND NAVIGATION THROUGHOUT THE PUMP WAS POSSIBLE. THE REPORTER STATED THAT PRIOR TO THIS ISSUE OCCURRING, THE PATIENT HAD BEEN WEARING THE PUMP IN THE SPRINKLER. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DELIVERY INTERRUPTION ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241862 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR