BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142292 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33458
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    August 30, 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
    FL
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL AT THE TIME OF THE CALL. TROUBLESHOOTING FOUND THE CUSTOMER'S DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THERE WAS ALSO NO AIR FOUND IN THE CUSTOMER'S TUBING. INSULIN WAS ALSO ABLE TO EXIT FROM THE TUBING DURING A MANUAL PRIME. CUSTOMER ALSO REPORTED HIS CANULA WAS NOT BENT. CUSTOMER ALSO STATED HIS BLOOD GLUCOSE WAS 44 MG/DL EARLIER THIS MORNING. HE STATED HE HAD TREATED HIS BLOOD GLUCOSE WITH ORANGE JUICE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622059 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 61 YR