BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6036674 · Received October 18, 2016

    Report

    Report Number
    2531779-2016-28926
    Event Type
    Injury
    Date Received
    October 18, 2016
    Report Date
    September 21, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 12/01/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX CONFIRMS THAT THE TIME/DATE RESET TO DEFAULT SETTING AFTER POR ON (B)(6) 2016 AT 22:32, DELIVERIES RESUMED AT 23:05. THE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY SETTINGS (TIME/DATE RESET) ISSUE. THE REPORTER STATED THAT THE TIME AND DATE RESET TO DEFAULT WHEN THE BATTERY WAS REMOVED FROM THE PUMP FOR LESS THAN 24 HOURS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING RULED OUT BASED ON THE FOLLOWING: 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 TO CONFIRM THE VERIFY SCREEN. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 47MG/DL WITH COGNITIVE IMPAIRMENT. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689034 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening