BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3153553 · Received June 8, 2013

    Report

    Report Number
    2531779-2013-07893
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 9/09/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/12/2017 WITH THE FOLLOWING FINDINGS: DURING VISUAL INSPECTION OF THE PUMP, IT WAS OBSERVED THAT THERE WAS NO DAMAGE OR PEELING TO KEYPAD. THE "UP", "DOWN" AND "OK" AND CONTRAST BUTTONS WERE INTERMITTENTLY RESPONSIVE TO USER PRESSES DURING THE INVESTIGATION. THE KEYPAD COVER WAS REMOVED AND THERE WAS STRONG CONTAMINATION FOUND UNDER ALL THE BUTTON CONTACTS. THE INVESTIGATION WAS ABLE TO DUPLICATE THE INITIAL COMPLAINT ABOUT UNDER RESPONSIVE KEYPAD BUTTONS. UNRELATED TO THE INITIAL COMPLAINT, IT WAS OBSERVED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY CAP AND CARTRIDGE CAP WERE NOT RETURNED WITH THE PUMP AND TEST CAPS WERE USED TO COMPLETE THE INVESTIGATION. 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 CHANGES/UNRESPONSIVE) ISSUE. EDUCATOR REPORTS THE DEMO PUMP'S UP AND DOWN ARROWS WERE RESPONDING INTERMITTENTLY. 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
    257209 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1