BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123335 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29517
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    THE CUSTOMER STATED THAT THEY HAD BEEN HAVING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST ONE OR TWO MONTHS AND HAD TO USE MANUAL INJECTIONS EVERY NOW AND THEN. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. THE CUSTOMER STATED THAT THEY THINK THE INSULIN PUMP WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. TROUBLESHOOTING WAS OFFERED, BUT THE CUSTOMER STATED THAT THEY WERE GOING TO THEIR DOCTOR'S APPOINTMENT AND WOULD SEE IF TROUBLESHOOTING COULD BE PERFORMED THERE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602513 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR