BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972332 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05136
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HIGH BLOOD GLUCOSE AND SYMPTOMS OF A STRANGE SMELL IN HER NOSE, SHAKES, HEADACHE, MOOD SWINGS, AND FLU-LIKE SYMPTOMS. THE BLOOD GLUCOSE READING WAS 180 MG/DL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL AND RECESSED. CUSTOMER WAS ASSISTED IN RUNNING A MANUAL PRIME AND STATED THAT INSULIN DID EXIT FROM THE TUBING. CUSTOMER FOUND NO LEAKS. THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. CUSTOMER STATED THAT THE INSULIN PUMP WAS THEN IN A PRIME CYCLE WHICH SHE COULD NOT EXIT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448576 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR