BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801403 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-12988
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT AND AL HISTORIES AND BLACK BOX DATA FOR EVENT HAVE BEEN OVERWRITTEN. CURRENT PUMP HISTORY SHOWS NO ERRORS, ALARMS, OR WARNINGS. THE TOTAL DAILY DOSE ADDS UP CORRECTLY. THE PUMP PASSED A DELIVERY ACCURACY TEST SUCCESSFULLY. THE BATTERY COMPARTMENT IS CRACKED FROM THE THREADS TO THE CASE SEAL. THE BATTERY CAP WAS NOT RETURNED AND A NEW TEST CAP WAS ABLE TO TIGHTEN TO THE PUMP AND WAS USED TO COMPLETE TESTING. THE AUDIO BOLUS BUTTON COVER WAS FOUND TO BE TORN BUT FULLY RESPONSIVE TO USER PRESSES. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT WAS OVERWRITTEN. UNRELATED TO THE COMPLAINT, THE DISPLAY LENS WAS SCRATCHED AND THE OK SYMBOL WAS FOUND TO BE WORN. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278957 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR