BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183276 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05432
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE PATIENT'S MOTHER REPORTED THAT FOR (B)(6) THE PATIENT OBTAINED ELEVATED BLOOD GLUCOSE LEVELS RANGING FROM 200 MG/DL TO 400 MG/DL. THE PATIENT EXPERIENCED THE SYMPTOMS OF "DRY HEAVING" AND TESTED (B)(6). DURING THE TROUBLESHOOTING TELEPHONE CALL, IT WAS DETERMINED THE PUMP'S PROGRAMMING WAS CORRECT, THE TOTAL DAILY DOSE TOTALS MATCHED THOSE PROGRAMMED AND THERE WERE NO ISSUES REPORTED WITH THE INFUSION SITE, INFUSION SET OR INSULIN CARTRIDGE. IT WAS ALSO DETERMINED THE PUMP'S TIME WAS SET INCORRECTLY, WHICH CAN CONTRIBUTE TO INCORRECT INFUSIONS. THE PATIENT HAD THE INCORRECT TIME PROGRAMMED INTO THE PUMP. THERE IS NO EVIDENCE THE PUMP WAS NOT FUNCTIONING APPROPRIATELY. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening