BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3253716 · Received July 30, 2013

    Report

    Report Number
    2531779-2013-12075
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 09/27/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 09/06/2013 WITH THE FOLLOWING RESULTS: CONFIRMED THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED UPON START UP AND DIFFICULT TO READ. REPLACED FADED DISPLAY WITH TEST DISPLAY, WHICH IS FULLY FUNCTIONAL AND ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION OF TEXT. UNRELATED TO THE COMPLAINT, OBSERVED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'OK','UP','DOWN' AND 'CONTRAST' BUTTONS. THE KEYPAD WAS UNDAMAGED AND WHEN THE COVER WAS REMOVED, CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. REPORTEDLY, THE DISPLAY SHOWED A PIXEL COLOR CHANGE AND THE TEXT WAS FADED/DIM. 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
    356361 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1