BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172966 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08318
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/07/2013 WITH THE FOLLOWING FINDINGS: DURING AN EVALUATION OF THE PUMP, THE DISPLAY SCREEN WAS CONFIRMED TO BE DISCOLORED. A TEST SCREEN WAS INSTALLED AND DISPLAYED PROPERLY. DURING TESTING, A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE PEELING BY THE CONTRAST KEYPAD BUTTON. ALL THE KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. ADDITIONALLY, THE PUMP¿S CASE WAS FOUND TO BE CRACKED NEAR THE OK KEYPAD BUTTON.

    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. 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 DIABETES EDUCATOR CONTACTED ANIMAS AND REQUESTED THAT ANIMAS CONTACT PATIENT REGARDING A DISPLAY ISSUE. ANIMAS CALLED THE PATIENT WHO ALLEGED THE FOLLOWING : THE PUMP WAS DROPPED AND HIT THE BED POST SEVERAL MONTHS AGO, AND ABOUT 4 MONTHS AGO THE PATIENT NOTICED THE PUMP DISPLAY WAS AT FIRST CHANGING COLORS, AND IS NOW DIM AND FADED. THE PATIENT DENIES GETTING PUMP WET. PATIENT REPORTS BLOOD GLUCOSE (BG) LEVELS HAVE RANGED FROM 22 MG/DL WITH SHAKING AND SWEATING TO 450 MG/DL WITH HEADACHE AND OCCASIONAL NAUSEA PATIENT FEELS THESE SWINGS MAY BE OCCURRING BECAUSE SHE CANNOT READ THE SCREEN SAFELY. SHE HAS NOT LOST CONSCIOUSNESS AND HAS BEEN ABLE TO TREAT SELF LOWS WITH PEANUT BUTTER SANDWICH AND JUICE; BOLUSES BY PUMP ONLY FOR HIGH BG AND MAY CHANGE OUT SITE IF NEEDED. CUSTOMER SUPPORT (CS) ADVISED PATIENT IN THE FUTURE TO CALL IMMEDIATELY AND IF SHE CANNOT READ PUMP SAFELY, TO GO TO AN ALTERNATE PLAN OF INSULIN DELIVERY. THE PATIENT IS CURRENTLY USING A DEMONSTRATION PUMP GIVEN TO HER BY THE EDUCATOR. THE ELEVATED BG DOES NOT MEET THE CRITERIA OF AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA IN ASSOCIATION WITH THE DISPLAY BEING DIM AND HARD TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272980 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening