BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2031080 · Received March 16, 2011

    Report

    Report Number
    3004209178-2011-80669
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS AND BLOOD GLUCOSE DROPPING TOO FAST, WHICH RESULTED IN CONVULSIONS. THE CUSTOMER'S FATHER STATED THAT PRIOR TO THE EVENT, HE HAD GIVEN THE CUSTOMER A BOLUS AND CHANGED OUT HIS SET BECAUSE THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S FATHER ALSO STATED THAT THE FILLING CANNULA WAS SET TO 4.3 UNITS INSTEAD OF 0.3 UNITS, WHICH CAUSED THE CUSTOMER TO GET 4 UNITS EXTRA OF INSULIN. THE CUSTOMER'S FATHER THEN STATED THAT HE WAS TOLD THE EVENT WAS CAUSED BY THE FIXED PRIME BEING SET TO THE WRONG AMOUNT. 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-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization