BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3231284 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11069
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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 10/11/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A TORN KEYPAD, ON TOP OF THE ¿OK¿,¿UP¿ AND ¿DOWN¿ BUTTONS. THE "CONTRAST¿,¿OK¿,¿DOWN¿ AND "UP" BUTTONS WERE UNRESPONSIVE TO TESTING. THE KEYPAD WAS REMOVED TO INVESTIGATE AND CONTAMINATION WAS OBSERVED UNDER THE ¿CONTRAST¿,¿OK¿,¿DOWN¿ AND "UP" CONTACT BUTTONS. THE ¿OK¿ AND "DOWN" CONTACT BUTTONS WERE OBSERVED TO BE INVERTED. THE AUDIBLE SOUND LEVEL COULD NOT BE TESTED DUE TO THE UNRESPONSIVE KEYPAD. UNRELATED TO THE INITIAL COMPLAINT, THE PUMP WAS BOOTED AND DISPLAY SCREEN WAS OBSERVED TO BE DIM WITH PINK CONTRAST. THE PUMP COVER WAS REMOVED AND REPLACED WITH A NEW TEST SCREEN AND CONTRAST RETURNED TO NORMAL WITH TEST SCREEN. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE THE REPORTER INDICATED THAT THE 'UP' AND 'DOWN' KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY RESPONSIVE FOR THE PAST 3 WEEKS. 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
    331555 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR