BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3964472 · Received July 29, 2014

    Report

    Report Number
    2531779-2014-21711
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 27, 2014
    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 PRODUCT 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HOSPITALIZATION FOR A BLOOD GLUCOSE OF 33 MMOL/L WITH SYMPTOMS OF NAUSEA, VOMITING, EXHAUSTION, JOINT PAIN, AND UNSPECIFIED KETONES. THE PUMP WAS REVIEWED AND CONFIRMED THAT THE PUMP SETTINGS WERE CORRECTLY PROGRAMMED, THE BASAL DELIVERIES CORRECTLY REFLECTED PROGRAMMED RATES AND MATCHED THE TOTAL DAILY DOSE DELIVERY, AND THE BOLUS DELIVERIES WERE SHOWN AS PROGRAMMED AND THE BOLUSES MATCHED THE TOTAL DAILY DOSE HISTORY. THE REPORTER INDICATED SHOWING SYMPTOMS OF POSSIBLE ILLNESS AND HAD CHANGES IN STRESS LEVELS RELATED TO THE EVENT. DURING REVIEW OF THE EVENT, THE REPORTER INDICATED THAT THE INSULIN USED IN THE PUMP MAY HAVE BEEN STORED INCORRECTLY. THE REPORTER ALSO INDICATED THAT THE CANNULA WHEN REMOVED FROM THE INFUSION SITE ALSO HAD BLOOD IN THE CANNULA; ANIMAS DOES NOT MANUFACTURE THE INFUSION SET, BUT HAS FORWARDED TO THE MANUFACTURER. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441288 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L