BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090995 · Received May 3, 2011

    Report

    Report Number
    2032227-2011-01140
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 525 MG/DL. THE CUSTOMER WAS GOING TO GIVE HERSELF A BOLUS WHEN SHE NOTICED THAT THE SCREEN WAS FROZEN, AND THE BUTTONS WERE NOT RESPONDING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME, HIGH PRESSURE AND SELF TESTS. FOUND BATTERY OUT LIMIT AND NO DELIVERY ALARMS IN THE ALARM HISTORY. ALSO, FOUND THAT THE CUSTOMER HAS BEEN INSERTING ONLY IN HER ABDOMEN FOR YEARS. ADVISED THE CUSTOMER TO ROTATE HER INSERTION SITES TO AVOID SCAR TISSUE. 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-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization