BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2041753 · Received March 29, 2011

    Report

    Report Number
    3004209178-2011-80849
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 WAS HOSPITALIZED DUE TO HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 141 MG/DL. THE CUSTOMER'S HUSBAND STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD TREATED HERSELF FOR A LOW BLOOD GLUCOSE READING OF 135 MG/DL, WHICH CAUSED HER BLOOD GLUCOSE LEVEL TO FALL TO 31 MG/DL. THE CUSTOMER'S HUSBAND FURTHER STATED, THAT THE CUSTOMER THEN TOOK GLUCAGON AND HER BLOOD GLUCOSE LEVEL ROSE TO OVER 359 MG/DL. THE PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND WAS STILL SENSITIVE TO BACK PRESSURE. 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 PUERTO RICO OPERATIONS MED-REL MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization