BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4162067 · Received October 10, 2014

    Report

    Report Number
    2531779-2014-28866
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 26, 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 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. PUMP FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. NO ALARMS OCCURRED DURING 24HR DURATION TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 486 MG/DL WITH EXTREME THIRST, FREQUENT URINATION, AND MILD SHORTNESS OF BREATH WHICH HAS RESOLVED. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND NO POTENTIAL CAUSES OF PERCEIVED INACCURATE DELIVERY ISSUE: PUMP SETTINGS AND HISTORIES WERE AS EXPECTED. CS ATTRIBUTED THE BG EXCURSION TO A CHANGE IN HYDRATION LEVEL (FLUIDS LOST THROUGH PERSPIRATION WERE NOT ADEQUATELY REPLACED). THE PATIENT CONTINUES ON THE PUMP. THERE IS NO INDICATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643339 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening