BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3033387 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03496
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED ON THE PUMP AND HAD DISPLAYED PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT THE DISPLAY SCREEN WAS HARD TO SEE. THE DISPLAY SCREEN ISSUE REPORTEDLY HAS BEEN OCCURRING FOR 6 MONTHS TO A YEAR. THE PATIENT STATED THAT SHE WAS UNABLE TO SEE THE DISPLAY SCREEN IN CERTAIN LIGHTING. THE PATIENT REPORTEDLY CHANGED THE BATTERY AND WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT DENIED DAMAGE TO THE PUMP OR THAT THE PUMP WAS EXPOSED TO MOISTURE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE THE ALLEGED DISPLAY SCREEN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137223 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR