BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3913634 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19111
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 HAD A BLOOD GLUCOSE (BG) OF 371 MG/DL, WITH EXCESS URINATION AND THIRST, AND MODERATE KETONES. THE PATIENT CONSULTED THE HEALTH CARE PROVIDER, CHANGED THE INSERTION SITE, AND SELF-TREATED WITH INSULIN VIA INJECTION AND VIA PUMP. PATIENT STATES THEY PROGRAMMED 2 BOLUSES THAT ARE NOT RECORDED IN HISTORY, FOR BG CORRECTION. TROUBLESHOOTING WITH CUSTOMER SUPPORT DID NOT IDENTIFY A KNOWN CAUSE FOR THE MISSING BOLUS RECORDS AND THE PATIENT WAS ADVISED TO DISCONTINUE PUMP USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE ISSUE OF THE MISSING BOLUS RECORDS WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391791 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening