BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2221255 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-82589
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 HIGH BLOOD GLUCOSE OF 777 MG/DL. THE CUSTOMER STATED THAT HE WAS WEARING THE INSULIN PUMP WHEN ADMITTED AND THEN HE WAS DISCONNECTED. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST FIVE DAYS AND HE WAS NOT GETTING ANY INSULIN. THE CUSTOMER'S MOST GLUCOSE READING WAS 55 MG/DL, AND HE WAS TREATED WITH FOOD. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING, TIME, AND DATE AND FOUND IN THE ALARM HISTORY A LOW RESERVOIR ALARM. RAN A FIXED PRIME AND HIGH PRESSURE TEST. THE CUSTOMER STATED THAT HE CAN ONLY USE THE ABDOMEN FOR SITES DUE TO PRIOR KIDNEY FAILURE. 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 68 YR Hospitalization