BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230874 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48406
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS PROVIDED BECAUSE ADDITIONAL EVENT DETAILS WERE REPORTED AFTER THE INITIAL REPORT WAS SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BENT CANNULA AND A LOW BLOOD GLUCOSE LEVEL OF 44 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS 278 MG/DL. NOTHING FURTHER REPORTED.

    Description of Event or Problem · 1

    THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713069 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR