BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2101566 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81552
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 562 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, SHE HAD BEEN HAVING HIGH BLOOD GLUCOSE LEVELS AND HAD FELT NAUSEATED. THE CUSTOMER ALSO STATED THAT SHE LAST CHANGED HER INFUSION SET THE DAY BEFORE THE EVENT. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS DONE AND THE INSULIN PUMP PASSED THE FIXED PRIME TEST. NOTHING FURTHER WAS REPORTED.

    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-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization