BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3072758 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04895
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/27/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS FOUND TO BE DIM/FADED. A TEST SCREEN WAS INSERTED AND FUNCTIONED APPROPRIATELY. UNRELATED TO THE DISPLAY ISSUE, THE KEYPAD WAS TORN OVER THE UP AND DOWN ARROW BUTTONS; ALL BUTTONS WERE RESPONSIVE AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. 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 INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM/FADED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/27/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175471 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR