BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3895719 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18325
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 19, 2014
    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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 08/31/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/07/2015 WITH THE FOLLOWING FINDINGS: THERE WAS NO DAMAGE FOUND TO THE KEYPAD. THE CONTRAST BUTTON WAS FOUND TO BE RESPONDING INTERMITTENTLY TO PRESSES; ALL OTHER BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO BUTTON PRESSES. A LEAK TEST WAS PERFORMED AND FOUND THAT THE PUMP WAS LEAKING FROM THE KEYPAD. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS OBSERVED ON THE PRINTED CIRCUIT BOARD. THE RETURNED BATTERY CAP WAS ABLE TO SECURE APPROPRIATELY TO THE PUMP FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE UP AND DOWN KEYPAD BUTTONS WERE UNDER RESPONSIVE TO BUTTON PRESSES. THE REPORTER INDICATED THAT THE KEYPAD WAS OBSERVED TO BE PEELING AND EVIDENCE OF MOISTURE WAS OBSERVED BEHIND THE DISPLAY SCREEN. 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
    372120 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR