BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3193046 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09122
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/25/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/16/2013 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED DELAYED/INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'OK' BUTTON. MULTIPLE BUTTON PRESSES ARE REQUIRED BEFORE THE 'OK' BUTTON ENGAGES. THE 'UP', 'DOWN' AND 'CONTRAST' BUTTONS RESPOND TO BUTTON PRESSES. NO VISIBLE DAMAGE ON THE KEYPAD. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. OBSERVED THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED AND DIFFICULT TO READ. THE CONTRAST SETTING IS SET AT '7'. INCREASED THE CONTRAST SETTING TO THE MAXIMUM OF '10' WITH LITTLE IMPROVEMENT OBSERVED. REPLACED FADED DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION OF TEXT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294691 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR