BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4240041 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-31980
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE AS LOW AS 51 MG/DL WITH SEVERE DIZZINESS AND/OR SEVERE HEADACHE, WAS HUNGRY, PALE AND MORE QUIET ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL CARBOHYDRATES AS NEEDED AND HAD DISCONTINUED PUMP THERAPY. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID NOT MATCH BECAUSE THE USER HAD MADE CHANGES TO THEIR BASAL PROGRAM. IT WAS REPORTED THAT THE PATIENT¿S HEALTHCARE PROVIDER HAD MADE RECENT CHANGES TO THEIR BASAL RATE AND BOLUS SETTINGS. ALSO DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE PUMP WAS DELIVERING THE BASAL RATE AS PROGRAMMED AND THE BOLUS TOTALS MATCHED THE PATIENT¿S PROGRAMMED SETTINGS AND THAT ALL WERE RECORDED AS PROGRAMMED. THE PATIENT WAS ABLE TO DELIVER ONE UNIT VIA AIR BOLUS WHILE ON THE PHONE WITH CTS WHICH WAS RECORDED CORRECTLY IN THE PUMP¿S HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA RELATED TO AN INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723333 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening