BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3172155 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08273
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    June 8, 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. 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 08/22/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/30/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD IS INTACT BUT THE KEYPAD SYMBOLS ARE WORN. THE CONTRAST, UP AND DOWN BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE OK BUTTON RESPONDED APPROPRIATELY. EVALUATION REVEALED CONTAMINATION UNDER ALL BUTTON CONTACTS. PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED. THERE WAS A CRACK ALONG THE BATTERY COMPARTMENT EXTENDING FROM THE THREADS TO THE CASE SEAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER INDICATED THAT THE DOWN ARROW BUTTON WAS INTERMITTENTLY RESPONDING FOR A COUPLE DAYS. THE REPORTER CONFIRMED NO DAMAGE TO THE KEYPAD. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273432 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR