BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2133701 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-81708
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 TREATED BY PARAMEDICS FOR HYPOGLYCEMIA, WITH BLOOD GLUCOSE OF 70 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER STATED THAT HER BLOOD SUGAR HAD DROPPED TO 54 MG/DL, WHICH SHE TREATED BY DRINKING 6.75 OUNCES OF JUICE. THE CUSTOMER THEN STATED THAT ELEVEN DAYS BEFORE THE EVENT, HER DOCTOR HAD CHANGED SOME OF THE SETTINGS ON HER INSULIN PUMP. THE CUSTOMER ALSO STATED THAT SHE HAD BEEN HAVING LOW BLOOD GLUCOSE LEVELS RANDOMLY AND LAST CHANGED HER INFUSION SET THE DAY BEFORE THE EVENT. THE CUSTOMER TREATED HERSELF WITH TEASPOONS OF SUGAR BECAUSE HER BLOOD GLUCOSE HAD CONSISTENTLY BEEN DROPPING FROM HER INITIAL BLOOD GLUCOSE READING. THE CUSTOMER STATED THAT THE PARAMEDICS HAD TREATED HER AND THAT HER BLOOD GLUCOSE WAS 119 MG/DL. PROGRAMMING WAS CORRECT. 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-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention