BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH

    MDR report key: 1973858 · Received January 18, 2011

    Report

    Report Number
    3004209178-2011-80164
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 REPORTED BEING IN THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE OF 44 MG/DL. THE CUSTOMER STATED THAT SHE KEPT HONEY UNDER HER TONGUE WHILE AT THE HOSPITAL AND LEFT THE MEDICAL FACILITY WITH A GLUCOSE READING OF 144 MG/DL. THE CUSTOMER STATED THAT SHE WAS NOT TREATED WITH ANY MEDICATION WHILE STAYING IN THE HOSPITAL. THE CUSTOMER INQUIRED ASSISTANCE ON HOW TO CHANGE SETTINGS FOR THE BOLUS WIZARD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization