BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4103110 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26843
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 6, 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 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 THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA WHILE ON PUMP THERAPY. REPORTEDLY, ON (B)(6) 2014, THE PATIENT¿S BLOOD GLUCOSE (BG) READING WAS AT 700 MG/DL WITH NAUSEA, DIZZINESS AND LARGE LEVEL OF KETONES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND WAS ADMINISTERED INTRAVENOUS FLUIDS AND GLUCOSE BY THE HEALTH CARE PROFESSIONALS (HCP). THE REPORTER STATED THAT THE PATIENT REMAINS HOSPITALIZED AT THE TIME OF THE CALL AND HAD RESUMED PUMP THERAPY ON THE SAME PUMP WITHOUT ANY RECENT ADJUSTMENT TO THE PUMP SETTINGS. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE POTENTIAL CAUSES FOR INACCURATE DELIVERY AND DETERMINED THAT ALL BASAL AND BOLUS DELIVERIES WERE CORRECT AND AS PROGRAMMED. REVIEW OF POTENTIAL CAUSES FOR BG ISSUE REVEALED THAT AFTER THE PUMP SETTINGS WAS PROGRAMED BY THE HCP, THE ADVANCED BOLUS AND INSULIN ON BOARD FEATURES WERE TURNED OFF AND THE PATIENT WAS GUESSING THE AMOUNT OF INSULIN FOR BEFORE MEAL BOLUSES. IN ADDITION, THE PATIENT ALLEGEDLY WAS MISCOUNTING CARBOHYDRATES AND WAS NOT USING BG RESULT IN CALCULATING THE AMOUNT OF INSULIN TO BOLUS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA ATTRIBUTABLE TO A USE ERROR IN THAT THE PUMP¿S BOLUS SETTINGS WERE NOT BEING USED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581860 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R