BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3946148 · Received July 21, 2014

    Report

    Report Number
    2531779-2014-20728
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Report Date
    July 7, 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

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. THE INVESTIGATION DID NOT OBSERVED ANY LINES ON THE DISPLAY SCREEN. UNRELATED TO THE REPORTED LINE THROUGH DISPLAY ISSUE, THE TEXT ON THE SCREEN WAS FOUND TO BE DIM AND DISCOLORED. RESETTING THE CONTRAST TO MAXIMUM SETTING SHOWED LITTLE IMPROVEMENT TO THE DIM DISPLAY ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE DISPLAY WAS 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
    424709 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1