BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222216 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10375
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ANIMAS WAS NOTIFIED THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 509MG/DL. THE PATIENT NOTED SOME TYPE OF ALARM OR SOMETHING WRONG WITH THE PUMP AT THE TIME OF THE BG EXCURSION. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA, AND IT WAS UNKNOWN HOW THE PATIENT TREATED THE BG ELEVATION. NO ADDITIONAL INFORMATION WAS PROVIDED. CUSTOMER TECHNICAL SUPPORT HAS MADE ATTEMPTS TO CONTACT THE PATIENT FOR TROUBLESHOOTING AND ADDITIONAL INFORMATION, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA POTENTIALLY RELATED TO AN ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322818 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening