BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822316 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14223
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT WAS HOSPITALIZED ON 05/04/2014 WITH DIABETIC KETOACIDOSIS AND AND BLOOD GLUCOSE OF 420 MG/DL. TREATMENT INCLUDED INSULIN VIA IV AND THE PUMP, AND IV FLUIDS. TROUBLESHOOTING WITH CUSTOMER SUPPORT FOUND THE REPORTER HAD NOT COMPLETED THE PRIME STEP AFTER CHANGING THE SITE/SET. ONLY PRIMED 0.6U FOR PRIME TOTAL AFTER SET CHANGE. NO PUMP MALFUNCTION WAS IDENTIFIED. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA SUBSEQUENT TO THE USER ERROR OF THE PUMP NOT BEING PROPERLY PRIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298760 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR