BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3230152 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11002
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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 11/27/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/19/2013 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED AN INTERMITTENT RESPONSE TO BUTTON PRESSES ON THE KEYPAD BUTTONS. MULTIPLE BUTTON PRESSES WERE REQUIRED BEFORE THE KEYPAD BUTTONS TO REGISTER. THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE INITIAL COMPLAINT, THE BOLUS BUTTON WAS INTERMITTENT TO BUTTON PRESSES AND WAS HARD TO PUSH. THERE WAS A HOLE VISIBLE ON THE COVER. THE INTERNAL PLUG CONTACT WAS FOUND TO BE MISALIGNED AND CONTAMINATION WAS PRESENT. THE PUMP BOOTED TO THE VERIFY SCREEN WITH A DIM PINK CONTRAST. THE OLED SCREEN WAS REMOVED AND REPLACED WITH A NEW TEST SCREEN WHICH CAUSED THE CONTRAST TO RETURN TO NORMAL. 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, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE KEYPAD BUTTONS ON THEIR DEVICE WERE DELAYED IN RESPONDING TO INPUTS. THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329962 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR