BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113551 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06444
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) OVER 500MG/DL WITH BLURRY VISION, HEADACHE, AND FEELING SICK SINCE (B)(6) 2013. THE REPORTER ALLEGED THAT THE PUMP IS NOT RECORDING BOLUSES AND INSULIN IS NOT BEING DELIVERED. THE REPORTER STATED THAT THREE TIMES IN THE PAST THREE DAYS A BOLUS HAD BEEN PROGRAMMED AND SHE HAS WATCHED THE BOLUS COUNT DOWN, BUT THEN THE BOLUS IS NOT IN THE HISTORY. THE REPORTER STATED THAT THE PATIENT'S BG IS TREATED WITH A CORRECTION INJECTION AND BG STABILIZES FOR A COUPLE OF HOURS. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING AT THE TIME OF INITIAL CONTACT. CUSTOMER TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER FOR TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING BOLUSES AS PROGRAMMED, RESULTING IN HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214707 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening