BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3103342 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06119
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD IS FULLY INTACT BUT THE KEYPAD SYMBOLS WERE FOUND TO BE WORN. ALL KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. EVALUATION REVEALED THAT CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. PUMP COVER WAS REMOVED AND THE OLD SCREEN WAS REMOVED AND REPLACED WITH A NEW TEST SCREEN, CONTRAST RETURNED TO NORMAL WITH TEST SCREEN.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE. 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
    203396 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1