BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182491 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82209
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 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
    MD, 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

    IT WAS REPORTED THAT THE CUSTOMER LOW BLOOD GLUCOSE AND THE SENSOR DID NOT DETECT. THE CUSTOMER HAD A SEIZURE AND COLLAPSED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER THEN WAS HOSPITALIZED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER REMOVED THE RESERVOIR FROM THE INSULIN PUMP AND PUT IT IN HIS POCKET TO DISCONNECT. IT WAS STATED THE INSULIN PUMP IS ALWAYS DISCONNECTED DURING THE MANUAL PRIME. RAN A DISPLACEMENT TEST AND PASSED. NO FURTHER INFORMATION WAS 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization