BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4943298 · Received July 27, 2015

    Report

    Report Number
    3004209178-2015-78259
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    February 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE ON (B)(6) 2015. THE CUSTOMER REPORTED THEIR BLOOD GLUCOSE RISING TO 600 MG/DL. THE CUSTOMER WAS ABLE TO LOWER THEIR BLOOD GLUCOSE TO 213 MG/DL. THE CUSTOMER ALSO REPORTED THEY WERE ADMITTED INTO URGENT CARE THE FRIDAY BEFORE THEIR HIGH EVENT. THE CUSTOMER STATED THEY WERE BEING TREATED FOR BRONCHITIS AND WAS GIVEN COUGH SYRUP AND ANTIBIOTICS FOR TREATMENT. CUSTOMER WAS ADVISED THESE MEDICATIONS CAN CAUSE HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485807 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other