BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3234002 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11309
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 10, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 12/23/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/12/2013 WITH THE FOLLOWING FINDINGS:THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD. THE KEYPAD BUTTONS WERE TESTED AND FOUND THAT THE BUTTONS WERE ALL RESPONDING APPROPRIATELY TO PRESSES. THE KEYPAD WAS REMOVED AND NO BUTTON CONTACT OR FLEX DEFECTS WERE FOUND. PUMP WAS OPENED TO CHECK CONDITION OF THE KEYPAD FLEX AND CONNECTOR..UNRELATED TO THE COMPLAINT, DURING TESTING, THE DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED EVEN WHEN ADJUSTED TO MAXIMUM CONTRAST. ALSO UNRELATED, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED; THERE WAS NO MOISTURE DAMAGE NOTED IN THE BATTERY COMPARTMENT AND THERE WERE NO POWER ISSUES NOTED DURING TESTING. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE UP ARROW BUTTON REQUIRED MULTIPLE PRESSES TO RESPOND AND NOW WAS COMPLETELY UNRESPONSIVE. THE REPORTER CONFIRMED THAT THE KEYPAD WAS INTACT. 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
    333180 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR