BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2233955 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82800
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 PROD 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 AT THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 326 MG.DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER ALSO WAS GIVEN HERSELF MANUAL INJECTIONS TO LOWER HER GLUCOSE LEVEL. THE PROGRAMMING WAS CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND PASSED. THE CUSTOMER MENTIONED TAKING MEDICATIONS. THE CUSTOMER PERFORMED AN INFUSION SET CHANGE AND RECEIVED A NO DELIVERY ALARM. ADVISED THE CUSTOMER TO DISCONNECT AT QUICK RELEASE, AND THEN PERFORM THE FILL CANNULA TEST, AND THE INSULIN EXITED. IT WAS STATED WHILE THE INFUSION SET WAS CHANGED, THE CUSTOMER DID NOT TAKE OFF THE NEEDLE GUARD AND WAS STUCK ON THE ADHESIVE PATCH. INSTRUCTED THE CUSTOMER TO CHECK THE INSERTION AREA AND NOTICED A LUMP UNDER THE SKIN. ADVISED CUSTOMER TO CONTACT HER DR FOR INSTRUCTIONS. THE CUSTOMER STATED THAT SHE WILL TRY TO REMOVE HERSELF. THE CUSTOMER PERFORMED THE INFUSION SET CHANGE SUCCESSFULLY. 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-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization