BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2123156 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01424
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OF APPROXIMATELY 900 MG/DL. THE CUSTOMER STATED THAT HE WAS FEELING FINE TWO DAYS BEFORE THE EVENT. ON THE DAY BEFORE THE HOSPITALIZATION, HE WAS FEELING SO SICK THAT HIS WIFE HAD TO TAKE HIM TO THE EMERGENCY ROOM, AND HE DOESN'T' REMEMBER ANYTHING THAT TOOK PLACE AFTER THAT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. 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-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION| SET, MMT-397, LOT 92010669