BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3073491 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04933
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/16/2016 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/02/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON AND DISPLAYED THE VERIFY SCREEN. THE DISPLAY WAS FOUND TO BE CLEAR AND LEGIBLE; THE DISPLAY FUNCTIONED APPROPRIATELY. THE COMPLAINT OF A DISPLAY ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING A DISPLAY SCREEN ISSUE. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME. 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
    173947 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR