BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6099547 · Received November 14, 2016

    Report

    Report Number
    2531779-2016-31277
    Event Type
    Injury
    Date Received
    November 14, 2016
    Report Date
    November 6, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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

    ON (B)(6) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT WAS VISITED THE EMERGENCY ROOM ON (B)(6) 2016 WITH HYPOGLYCEMIA. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 37 MG/DL WITH SYMPTOMS OF DEHYDRATION AND CONFUSION. THE PATIENT WAS ALLEGEDLY TAKEN TO THE ER AND TREATED WITH GLUCOSE TABLETS/GEL. THE PATIENT HAD REMAINED ON THE PUMP AT THE TIME OF THE CALL. THE REPORTER REVIEWED THE PUMPS HISTORY WITH A CUSTOMER TECHNICAL SUPPORT REPRESENTATIVE AND FOUND THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. THE REASON FOR THE VARIATION WAS DETERMINED TO BE CAUSED BY THE PATIENT MANUALLY CHANGING THEIR BASAL RATES. THE PATIENT WAS REFERRED TO THEIR HEALTHCARE PROVIDER FOR DIABETES MANAGEMENT ISSUES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT AS ALLEGEDLY WENT TO THE EMERGENCY ROOM WITH HYPOGLYCEMIA AS A RESULT OF USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752043 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R