BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2250962 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82795
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 REPORTED EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST FEW HOURS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 239 MG/DL, AND SHE HAS TREATED WITH MANUAL INJECTIONS. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND THE TEST PASSED. PERFORMED HIGH PRESSURE TEST SEVERAL TIMES AND THE INSULIN PUMP FAILED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR