BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132770 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07140
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: (B)(4) 2013. 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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX REVEALED THE TIME AND DATE WERE INCORRECT THROUGHOUT THE ENTIRE HISTORY. AS A RESULT, THE TOTAL DAILY DOSE HISTORY IN THE PUMP WAS RUNNING FROM THE FACTORY DEFAULT SETTING SINCE 11/19/2012. NO TIME/DATE ISSUE WAS OBSERVED. ON TESTING, THE PUMP POWERED ON PROPERLY TO THE VERIFY SCREEN. THE DISPLAY WAS NOTED TO BE DIM. A TEST DISPLAY WAS ATTACHED TO THE PUMP WITH ILLUMINATED PROPERLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS. THE PUMP WAS POWERED OFF ON (B)(4) 2013 FOR A TOTAL OF 70 MINUTES¿ TIME. WHEN THE PUMP WAS REBOOTED, THE TIME AND DATE HAD NOT BEEN MAINTAINED PROPERLY. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED THE INTERNAL BATTERY WAS LEAKING. ADDITIONALLY, THE BOLUS BUTTON COVER WAS NOTED TO BE TORN EXPOSING THE SLUG CONTACT UNDERNEATH. THE AUDIO BOLUS BUTTON WAS RESPONSIVE WHEN TESTED. THE BOLUS BUTTON COVER WAS REMOVED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF CONTAMINATION OF THE CONTACT.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013. THE AUDIO BOLUS BUTTON WAS DAMAGED, BUT OPERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235116 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR