BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6584795 · Received May 23, 2017

    Report

    Report Number
    2531779-2017-10969
    Event Type
    Injury
    Date Received
    May 23, 2017
    Report Date
    May 21, 2017
    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 FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PATIENT SETTING OCCLUSION LEVEL TO HIGH ON PUMP). (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING AN OCCLUSION (FREQUENT/PERSISTENT) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 17.0MMOL/L TO 29.6MMOL/L WITH NAUSEA, DROWSINESS, CONFUSION AND LARGE KETONES IN THE URINE. THE PATIENT WAS TAKEN TO THE DOCTOR¿S OFFICE AND TREATED WITH INSULIN VIA INJECTION. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND INDICATED THAT THE OCCLUSION SENSITIVE WAS SET TO HI. CS ASSISTED THE PATIENT WITH CHANGING OCCLUSION SENSITIVITY. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED WHILE ON PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367111 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening