BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3960759 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21570
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN 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 HYPERGLYCEMIC EVENT ASSOCIATED WITH PUMP USE. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 549 MG/DL WITH NO SYMPTOMS OR KETONES AND NO REPORTED INTERVENTION ABOVE AND BEYOND USUAL DIABETES MANAGEMENT. REPORTEDLY, THERE WERE NO PUMP SETTING ADJUSTMENTS BEFORE OR AFTER THE ALLEGED EVENT AND THE PATIENT REMAINED ON THE PUMP. TROUBLESHOOTING DETERMINED THAT ALL BOLUSES WERE RECORDED AS PROGRAMMED; THE BASAL/TEMP BASAL SETTINGS WERE INCORRECTLY PROGRAMMED AND THE PATIENT HAD MISCOUNTED CARBOHYDRATES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH USE ERROR OF THE PUMP AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437700 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening