BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2112377 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81588
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE OVER 400 MG/DL. THE CUSTOMER STATED THAT SHE LAST CHANGED HER INFUSION SET THE DAY BEFORE THE EVENT. THE CUSTOMER ALSO STATED THAT FOLLOWING THE EVENT, SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVELS OVER 600 MG/DL AFTER CHANGING HER INFUSION SET TWICE THE NIGHT BEFORE. PROGRAMMING WAS CORRECT. 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 5 YR Hospitalization