BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132092 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07086
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE PUMP HAD VISIBLE MOISTURE IN THE DISPLAY LENS. THE PUMP DID NOT POWER ON AND HAD NO AUDIBLE OR VIBRATORY SOUNDS. THE PUMP HISTORY AND BLACK BOX DATA WAS NOT ABLE TO BE DOWNLOADED. DURING EVALUATION, A LEAK TEST WAS PERFORMED AND REVEALED A LEAK IN THE AUDIO BOLUS BUTTON. THE PUMP COVER WAS REMOVED AND INTERNAL MOISTURE WAS OBSERVED IN THE PUMP. FURTHER TESTING WAS UNABLE TO BE COMPLETED DUE TO INABILITY TO POWER ON THE PUMP AND MOISTURE INGRESS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 THAT THE BOLUS HISTORY IS NOT RECORDING DELIVERED BOLUSES. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING AT THE TIME OF INITIAL CONTACT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. CUSTOMER TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER TO COMPLETE TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP¿S BOLUS HISTORY WAS NOT RECORDING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235358 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR