BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3220597 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10305
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/25/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED IN THE PUMP BLACK BOX OR DOWNLOAD HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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

    THE REPORTER (MEDICAL STAFF AT THE HOSPITAL) CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS (DKA). THE REPORTER STATED THAT THE PATIENT WAS TAKING BOLUSES AS NORMAL AND THE PATIENT¿S HEALTH CARE PROVIDER HAD ADJUSTED THE PATIENT¿S PUMP SETTINGS ONE WEEK PRIOR TO ADMISSION. THE REPORTER WAS UNABLE TO PROVIDE A POSSIBLE REASON FOR THE PATIENT¿S DKA EPISODE. THE REPORTER STATED THAT THE PATIENT WAS PLACED BACK ON THE PUMP AND BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED AT 185 MG/DL AND INDICATED THAT THEY FELT THE PUMP WAS NOT DELIVERING INSULIN. THE REPORTER INDICATED THAT WHEN THE PATIENT WENT TO BOLUS FOR THE BLOOD GLUCOSE OF 185 MG/DL THE PUMP ADVISED NO BOLUS. THE REPORTER WAS ADVISED ON THE INSULIN ON BOARD FEATURE AND ADVISED ON THE POSSIBLE NEED TO ADJUST INSULIN TO CARBOHYDRATE OR INSULIN SENSITIVITY FACTOR RELATED TO HIGH BLOOD GLUCOSE LEVELS AFTER MEALS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321092 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L