BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6176187 · Received December 15, 2016

    Report

    Report Number
    2531779-2016-33685
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    November 19, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 03/17/2017 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/25/2017 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. PUMP WAS EXERCISED FOR 24 HRS. AFTER 24 HRS THE BATTERY WAS REMOVED FOR 6 HRS. THE BENCH TESTING CONFIRMED WHEN THE BATTERY WAS REINSERTED AFTER 6 HRS WITHOUT POWER THE TIME AND DATE RESET TO DEFAULT SETTING. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. REMOVED COVER; A VISIBLE INSPECTION CONFIRMED THE BT1 INTERNAL BATTERY WAS LEAKING. 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. (B)(4).

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2016 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASURING 350 MG/DL WITH ASSOCIATED SYMPTOMS OF EXTREME FATIGUE/DROWSINESS. THE PATIENT¿S HEALTH CARE PROVIDER REPORTEDLY HAD MADE ADJUSTMENTS TO THE BASAL RATE AND THE BOLUS SETTINGS IN THE PUMP. IT WAS ALLEGED THE PATIENT¿S HYPERGLYCEMIA WAS ASSOCIATED WITH A TIME//DATE SETTING ISSUE IN THE PUMP; THE TIME AND DATE GOES TO THE DEFAULT FOR THE PUMP MODEL IF THE BATTERY IS REMOVED FOR LESS THAN 24 HOURS. THIS ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET BY THE USER TO CONFIRM THE VERIFY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY WITH SETTINGS ADJUSTMENTS INVOLVED AS WELL AS A TIME/DATE SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829033 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR