BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090134 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81364
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    January 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 TWICE FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE LONG TIME AGO. THE CUSTOMER STATED THAT FIRST TIME HER BLOOD GLUCOSE WAS 1100MG/DL, AND THE SECOND TIME WAS OVER 800MG/DL AT TIME OF THE EVENT. THE CUSTOMER STATED THAT THE INSULIN PUMP IS NOT DELIVERING PROPERLY, AND SHE HAS A HARD TIME TO REMEMBER HOW TO REWIND THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE WAS BOLUSING FOR HER HIGH GLUCOSE, BUT HER GLUCOSE LEVEL DID NOT COME DOWN. TROUBLESHOOTING WAS PERFORMED THE INSULIN PUMP WAS ONE HOUR BEHIND. REVIEWED THE PROGRAMMING AND EVERYTHING SEEMS TO BE SET PROPERLY. FOUND THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP, AND HER BLOOD GLUCOSE WAS GOING HIGH. 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 63 YR Hospitalization