BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4202173 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37165
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HIGH BLOOD GLUCOSE. THE CUSTOMER REQUIRED ASSISTANCE WITH CHANGING THE INFUSION SET. BLOOD GLUCOSE READING WAS 461 MG/DL. THE CUSTOMER WAS ON DIFFERENT MEDICATIONS FOR A BACK SURGERY PERFORMED RECENTLY. CUSTOMER'S MOTHER BELIEVES THAT THE MEDICATIONS ARE CAUSING BLOOD GLUCOSE ISSUES. THE CUSTOMER HAD TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REFUSED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE AND ONLY WANTED ASSISTANCE WITH CHANGING THE INFUSION SET. ASSISTANCE WAS PROVIDED AND THE CUSTOMER WAS ABLE TO DELIVER A CORRECTION BOLUS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649048 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR