BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3983143 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22491
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 25, 2014
    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

    (B)(6). 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. UNRELATED TO THE COMPLAINT, THE UP AND DOWN KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE. THE OK AND CONTRAST BUTTONS WERE FOUND TO RESPONSIVE. THERE WAS NO DAMAGE FOUND TO THE KEYPAD COVER. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE 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

    ON (B)(6) 2014, THE DISTRIBUTER CONTACTED ANIMAS AND REPORTED A DIM, FADED AND DISCOLORED DISPLAY SCREEN. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461784 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1