BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3760383 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10573
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 31, 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

    (B)(6). THE DEVICE WAS RETURNED AND INVESTIGATED ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THERE WERE SURFACE CRACKS ON THE DISPLAY LENS. ON INVESTIGATION THE PUMP POWERED ON WITH A DIM, FADED, DISCOLORED DISPLAY SCREEN. ADJUSTMENT OF THE CONTRAST SETTING DID NOT RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) 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
    241176 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1