BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2032340 · Received March 22, 2011

    Report

    Report Number
    2032227-2011-00728
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 20, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS THAT WERE OUT OF RANGE. PRIOR TO THE EVENT, THE CUSTOMER WAS TAKING A SHOWER, AND PASSED OUT. THE CUSTOMER DID NOT GET ANY NO DELIVERY ALARMS. WHEN THE INFUSION SET WAS REMOVED, THE DOCTOR STATED THAT THE CANNULA HAD NO HOLE FOR THE INSULIN TO EXIT. THE WIFE STATED THAT THEY WILL BE KEEPING THE INFUSION SET AND TAKING IT TO AN ATTORNEY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER WAS USING A MODEL MMT-399 INSULIN INFUSION SET. 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 MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization (B)(4) QUICK-SET PARADIGM INSULIN INFUSION SET