BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142097 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33399
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 1800 MG/DL. CUSTOMER'S SYMPTOMS WERE VOMITING, DIZZINESS, AND PASSING OUT. CUSTOMER REPORTED HE WAS DRIVING AND THE DEVICE STARTED BEEPING AS HE PULLED IN HE STARTED VOMITING ALL OVER THE CAR. CUSTOMER STATED HE HARDLY REMEMBERS WHAT OCCURRED BUT DID RECALL STATING HE NEEDED TO CHANGE HIS SET STARTED GETTING DIZZY AND PASSED OUT SPITTING UP BLOOD. CUSTOMER WENT INTO A DIABETIC COMA. CUSTOMER DOES NOT THINK THE DEVICE WAS TAKEN OFF. CUSTOMER RECALLED WAKING UP THREE TIMES AND STATING HE HAD TO CHANGE HIS SET AND PASSING BACK OUT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621302 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization