BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4181484 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39596
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 518 MG/DL. SHE STATED SHE HAD WOKEN UP IN THE MORNING WITH HIGH BLOOD GLUCOSE AND WAS FEELING NAUSEOUS WITH BODY ACHES. THE CUSTOMER STATED SHE HAD TREATED HER BLOOD GLUCOSE WITH THE INSULIN PUMP. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING. THE CUSTOMER ALSO REPORTED THERE WAS NO LEAKS ON THE INSULIN PUMP. THE CUSTOMER'S BOLUS HISTORY WAS ALSO CORRECT. THE CUSTOMER WAS ADVISED TO CHANGE OUT HER ENTIRE INFUSION SET, RESERVOIR, AND INSULIN. THE CUSTOMER STATED HER BLOOD GLUCOSE HAD DECLINED TO 430 MG/DL AT THE END OF THE CALL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660927 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR