BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2002571 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80443
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR KEYTONES AND HIGH BLOOD GLUCOSE OF OVER 400 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH AN INSULIN DRIP. THE CUSTOMER CALLED BACK AND STATED THAT HE WAS NOT SURE IF HE TOOK HIS BOLUS AND THEN GOT SICK. THE CUSTOMER STATED THAT HE WAS NOT CONNECTED BACK TO THE INSULIN PUMP AND REQUESTED ASSISTANCE ON TURNING OFF THE ALARMS. NO FURTHER INFORMATION 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-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization