BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3163667 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08107
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 08/13/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/18/2013 WITH THE FOLLOWING FINDINGS: THE PUMP DISPLAY SCREEN WAS FOUND TO BE FULLY FUNCTIONAL AND WAS FULLY ILLUMINATED WITH NO SIGNS OF VISIBLE DAMAGE, FADING, OR DISCOLORATION. THE PUMP ALARM HISTORY WAS REVIEWED AND FOUND NO INDICATION OF AN ISSUE RELATED TO THE EVENT. THE PUMP WAS OPENED AND THERE WAS NO DAMAGE TO THE DISPLAY, FLEX, OR CONNECTOR. UNRELATED TO THE COMPLAINT, THERE WERE NO AUDIBLE TONES OBSERVED DURING THE PUMP START UP. THE PUMP AUDIBLE ALARM SYSTEM WAS EXAMINED AND THE ELECTRICAL CONTACT PINS ON THE PIEZO WERE FOUND TO BE PARTIALLY DISLODGED. THE PIN WAS RESEATED AND THE PUMP AUDIBLE TONES RETURNED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE DISPLAY ON THE ANIMAS PUMP REPORTEDLY HAS A BLANK SCREEN AFTER HE REPLACED THE BATTERY. THERE WAS NO TRAUMA OR MOISTURE ISSUE. THE CONTRAST WAS SET ACCORDINGLY BUT THE ISSUE IS NOT RESOLVED. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263746 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR