BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3060249 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04285
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: NO FUNCTIONAL DEFECT WAS FOUND WITH THE PUMP. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. THE TOTAL DAILY INSULIN TOTALS WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. REMOVED THE PUMP COVER AND REPLACED FADED DISPLAY WITH TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST WITH NO VISIBLE SIGNS OF DISCOLORATION. 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

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM/DIFFICULT TO READ. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162474 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR