BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4013362 · Received August 15, 2014

    Report

    Report Number
    2531779-2014-23556
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    August 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/06/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE BATTERY CAP WAS NOT RETURNED AND A TEST CAP WAS USED IN THE EVALUATION. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUES WERE FOUND WITH THE BUTTONS. THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE REPORTED DISPLAY ISSUE WAS DUPLICATED IN THE INVESTIGATION.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THERE WAS PIXEL COLOR CHANGE TO THE DISPLAY. 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
    491090 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1