BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3931911 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19869
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 AS FOLLOWS: THE KEYPAD WAS OBSERVED TO BE FULLY INTACT. THE UP, DOWN, OK AND CONTRAST BUTTONS WERE INTERMITTENTLY UNRESPONSIVE TO TESTING. THERE WERE NO ERRORS, ALARMS OR WARNINGS RELATED TO THE COMPLAINT IN THE PUMP HISTORY. THE LAST BOLUS AND THE LAST BASAL DELIVERY WERE ON (B)(6) 2014. A LOW BATTERY WARNING WAS RECORDED ON (B)(6) 2014 16:12 AND THEN DELIVERIES WERE NOT RESUMED. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED AND THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE UP, DOWN, OK AND CONTRAST BUTTON CONTACTS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN HAD A PINKISH CONTRAST. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPOGLYCEMIC EVENT AND UNRESPONSIVE KEYPAD BUTTONS. REPORTEDLY, THE PATIENT HAD HAD AN AUTO ACCIDENT ON (B)(6) 2014 FOR WHICH EMS RESPONDED. IT WAS REPORTED THAT THE PATIENT WAS DISORIENTED WITH BLOOD GLUCOSE OF 38MG/DL AND EMS PERSONNEL ADMINISTERED GLUCOSE TABLETS. REPORTEDLY, THERE WERE NO PUMP SETTING CHANGES BEFORE OR AFTER THE ALLEGED EVENT AND THE PATIENT REMAINED ON THE PUMP. IT WAS REPORTED THAT THE PUMP HAD UNRESPONSIVE UP, DOWN, AND OK BUTTONS AND THAT THE PATIENT HAD OVERBOLUSED BREAKFAST. THE PATIENT STATED THAT THEY WERE NOT SURE IF THE KEYPAD ISSUE MAY HAVE CONTRIBUTED TO THE EVENTS SURROUNDING THE BG EXCURSION. THE PATIENT WAS ADVISED TO DISCONTINUE PUMP USE AND THE PUMP IS BEING REPLACED. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPOGLYCEMIA RELATED TO UNRESPONSIVE KEYPAD BUTTONS AND SUBSEQUENT OVER BOLUS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410420 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R