BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2133682 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-81711
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HYPOGLYCEMIA, WITH BLOOD GLUCOSE OF 57 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT SHE HAD BEEN HAVING LOW BLOOD GLUCOSE LEVELS FOR FIVE HOURS. THE CUSTOMER ALSO STATED THAT SHE LAST CHANGED HER INFUSION SET A DAY BEFORE THE EVENT. THE CUSTOMER FURTHER STATED THAT SHE CHANGED HER INFUSION SET EVERY THREE DAYS BUT CHANGED HER RESERVOIR ONLY ONCE A WEEK. IT WAS EXPLAINED TO THE CUSTOMER THAT IT IS RECOMMENDED TO CHANGE THE RESERVOIR AND INFUSION SET AT THE SAME TIME. THE CUSTOMER THEN MENTIONED THAT THERE WAS A POSSIBLE OVER-BOLUS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization