BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982327 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06179
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS NOT HOSPITALIZED DUE TO HAVING HIS FIFTH FOOT SURGERY. CUSTOMER IS NOT SURE IF THE INSULIN PUMP WAS RELATED TO THE HOSPITALIZATION. CUSTOMER STATED, THE DEVICE HAD ALARMED BATTERY OUT LIMIT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER DOES NOT KNOW HIS BLOOD GLUCOSE READING. CUSTOMER HAS PROBLEMS HEARING AND IS NOT SURE WHEN THE ALARM OCCURRED. CUSTOMER WAS ADVISED HOW TO FIND THE DEVICE ALARM HISTORY. CUSTOMER WAS ASSISTED WITH PROGRAMMING THE DEVICE. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457318 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization