BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2133685 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-81716
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    March 15, 2011
    Report Date
    May 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
    KY, 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 BEING HOSPITALIZED TWICE FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE OVER 1200 MG/DL DURING THE FIRST HOSPITALIZATION. THE CUSTOMER STATED THAT THE FIRST HOSPITALIZATION WAS DUE TO AN INFECTION, DURING WHICH SHE HAD ALSO RECEIVED MULTIPLE NO DELIVERY ALARMS. THE CUSTOMER ADDED THAT SHE HAD RECEIVED NO DELIVERY ALARMS ABOUT FOUR TIMES A WEEK. THE CUSTOMER THEN STATED THAT SHE WAS NOT WEARING THE INSULIN PUMP WHEN SHE WAS HOSPITALIZED FOR HYPERGLYCEMIA ABOUT THREE WEEKS AFTER THE FIRST HOSPITALIZATION. THE CUSTOMER ALSO STATED THAT SHE WAS USING A QUICK-SET INFUSION SET. 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-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET