BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3061454 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04347
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE DISPLAY IS FADED, DISCOLORED AND DIFFICULT TO READ. INVESTIGATORS REPLACED FADED DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE WORN. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING A DISPLAY DIM/FADING ISSUE. THE REPORTER INDICATED THAT THE PUMP SCREEN WAS GOING DIM VERY FAST FOR THE PAST 3 MONTHS. THERE IS NO INDICATION OF AN ADVERSE EVENT RELATED TO THIS ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE DISPLAY SCREEN ISSUE WHICH WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162649 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR