BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6041054 · Received October 19, 2016

    Report

    Report Number
    2531779-2016-29106
    Event Type
    Injury
    Date Received
    October 19, 2016
    Report Date
    September 25, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY SETTINGS (INACCURATE DELIVERY) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OVER 400 MG/DL WITH NAUSEA, VOMITING, ABDOMINAL PAIN, HEADACHE, SYMPTOMS OF DEHYDRATION, AND LARGE KETONES. THE PATIENT WAS HOSPITALIZED AND TREATED. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND THE BASAL HISTORY MATCHES THE ACTIVE BASAL PROGRAM SETTINGS AND THE BASAL DELIVERY TOTALS IN TDD MATCH ACTIVE BASAL PROGRAM TOTAL OR ARE AS EXPECTED. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692194 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization