BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3072260 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04858
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT'S BLOOD GLUCOSE (BG) HAS BEEN ELEVATED SINCE (B)(6) 2013. THE PATIENT'S CURRENT BG WAS REPORTED TO BE 573MG/DL 2 HOURS AFTER BOLUSING FOR BREAKFAST. THE REPORTER STATED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) WAS CONTACTED AND THEY WERE INSTRUCTED TO GIVE THE PATIENT A CORRECTION INJECTION AND TO CALL ANIMAS TO REVIEW THE PUMP. THE REPORTER STATED THAT THE SITE/SET WAS CHANGED THE EVENING OF (B)(6) 2013 AND HAD NOT BEEN CHANGED SINCE THEN. THE SITE WAS REMOVED DURING TROUBLESHOOTING AND THERE WERE NO SITE OR SET ISSUES FOUND. THE INSULIN WAS REPORTEDLY NOT EXPIRED. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER AND NO MECHANICAL ISSUES WERE FOUND; ALL SETTINGS AND HISTORIES WERE FOUND TO BE CORRECT AND THERE WERE NO CORRESPONDING ALARMS NOTED IN THE HISTORY. CTS ADVISED THE REPORTER TO CHANGE THE SITE, SET, AND CARTRIDGE AND TO MONITOR BGS, AND TO CONTACT THE PATIENT'S HCP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174948 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening