BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2111848 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81609
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT HE WAS TREATED BY PARAMEDICS FOR HYPOGLYCEMIA, WITH BLOOD GLUCOSE OF 38 MG/DL. THE CUSTOMER STATED THAT HE COULD NOT CHECK SETTINGS OF HIS INSULIN PUMP AS HE KEPT RECEIVING NO DELIVERY ALARMS. IT WAS FOUND THAT THE RESERVOIR WAS EMPTY AND SO THE NO DELIVERY ALARM WAS RESOLVED BY DOING AN INFUSION SET AND RESERVOIR CHANGE. THE CUSTOMER ALSO STATED THAT HE LAST CHANGED HIS INFUSION SET (B)(6) BEFORE THE EVENT. 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-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention