BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2202498 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82444
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 62MG/DL. THE CUSTOMER STATED THAT SHE WAS VOMITING AND PASSED OUT. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED LOW GLUCOSE FOR THE PAST DAY. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 207MG/DL, AND SHE HAS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. THE CUSTOMER STATED THAT THERE IS MORE INSULIN IN THE STATUS SCREEN THAN THE RESERVOIR. THE CUSTOMER STATED THAT SHE WAS RECEIVING SOME AUTO OFF ALARMS. THE CUSTOMER STATED THAT DOCTOR HAD SET IT TO TWELVE HOURS, BUT WHEN IT WAS CHECKED NO SETTINGS WERE FOUND. NO FURTHER INFO 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization