BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3971506 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21990
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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, ALLEGING THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO FREQUENT AND PERSISTENT OCCLUSION. REPORTEDLY, ON (B)(6) 2014, THE PATIENT¿S BLOOD GLUCOSE (BG) WAS OVER 500 MG/DL WITH LARGE LEVEL OF KETONE. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVED ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND THE PATIENT ALLEGEDLY REMAINED ON PUMP THERAPY WITH NO RECENT ADJUSTMENT TO PUMP SETTINGS. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE EVENT WITH THE REPORTER. THE CUSTOMER STATED THAT THEY HAD REPORTED ON THE SAME ISSUE MULTIPLE TIMES WITH MORE THAN ONE SET OF SUPPLIES. REVIEW OF USE TECHNIQUES FOR CARTRIDGES, INFUSION SET AND SITE INSERTION INDICATED THAT THE INSTRUCTION FOR USE WERE FOLLOWED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SERIOUS HYPERGLYCEMIA RELATED TO OCCLUSION ISSUES OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447660 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening