BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252141 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52838
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    IT WAS REPORTED THAT THE CUSTOMER VISITED THE EMERGENCY ROOM ON (B)(6) 2014 BECAUSE OF HER HIGH BLOOD GLUCOSE LEVEL OF 429 MG/DL. THE CUSTOMER CHANGED HER INFUSION SET BUT HER BLOOD GLUCOSE LEVEL DID NOT GO DOWN. HER MOST RECENT BLOOD GLUCOSE LEVEL WAS 407 MG/DL. THE CUSTOMER'S PREVIOUS INFUSION SET WAS FOUND OUT OF HER BODY. SHE TREATED HER HIGH BLOOD GLUCOSE LEVEL WITH A MANUAL INJECTION BOLUS OF 3 UNITS. THE INSULIN PUMP WAS WORN AT THE TIME OF EMERGENCY ROOM VISIT. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738066 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O