BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4870043 · Received June 25, 2015

    Report

    Report Number
    3004209178-2015-68886
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S SPOUSE CALLED AND REPORTED CUSTOMER WAS WORKING OUTSIDE WHEN HIS BLOOD GLUCOSE WENT LOW AND HE FELL AND BROKE HIS RIBS. HE WAS TAKEN TO THE HOSPITAL AND HIS BLOOD GLUCOSE WAS 48 MG/DL. THE PERCEIVED CAUSE OF LOW BLOOD GLUCOSE WAS OVERCORRECTION. CALLER DID NOT WISH TO PERFORM TROUBLESHOOTING WITH THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411715 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR