BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5002463 · Received August 13, 2015

    Report

    Report Number
    2032227-2015-29307
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    IT WAS REPORTED VIA INTERDEPARTMENTAL HELPLINE SOLUTIONS TRACKER THAT CUSTOMER HAD LOW BLOOD GLUCOSE OF 30 MG/DL AND 44 MG/DL. IT WAS REPORTED THAT DIABETES EDUCATOR ADJUSTED SETTINGS, AND CUSTOMER'S BLOOD GLUCOSE STABILIZED AT 200 MG/DL. IT WAS REPORTED THAT CUSTOMER HAD TROUBLE FEELING QUICKSERTER WITH FINGER TIPS AND THAT CUSTOMER ONLY HAD VISION IN ONE EYE. CUSTOMER DECLINED TRANSFER TO HELPLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534230 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other