BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2781609 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-90022
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 700MG/DL, AND HE WAS TREATED WITH MANUAL INJECTIONS. THE CUSTOMER EXPERIENCED NAUSEA AND VOMITING. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT HE WAS FEELING SICK FOR A COUPLE OF DAYS DUE TO AN INFECTION. THE CUSTOMER MENTIONED THAT HE CHANGED THE INFUSION SET AND HIS GLUCOSE LEVEL DROPPED FROM 500 TO 167MG/DL. THEN THE INSULIN PUMP STOPPED WORKING AND HIS GLUCOSE LEVEL WENT UP AGAIN. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE CALLER STATED THAT HE INSERTED THE INFUSION SET INCORRECTLY, AND HE CHANGED THE INFUSION SET THREE TIMES, BUT HIS GLUCOSE LEVEL STILL WENT UP. THE CUSTOMER FELL THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY AND REQUESTED THAT THE DEVICE BE REPLACE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization