BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3113220 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06428
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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

    (B)(6). 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 07/15/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/17/2013 WITH THE FOLLOWING FINDINGS:INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL. 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

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE DISPLAY SCREEN ON THE INSULIN PUMP WAS FADED OR DIM AND EXPERIENCED A PIXEL COLOR CHANGE. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED DISPLAY SCREEN DEFECT WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215639 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1