BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2072563 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-81161
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW POTASSIUM AND HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 721 MG/DL. THE CUSTOMER STATED THAT SHE USES A MIO INFUSION SET AND CHANGED HER INFUSION SET TWO DAYS BEFORE THE EVENT. THE CUSTOMER ALSO STATED THAT SHE GAVE HERSELF INSULIN WITH THE INSULIN PUMP THREE DAYS BEFORE THE EVENT, BUT THERE WAS NO RECORD OF ANY BOLUSES BEING DELIVERED THAT DAY. THE CUSTOMER THEN STATED THAT SHE DOES NOT KNOW HOW TO USE THE INSULIN PUMP VERY WELL. 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-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization UNOMEDICAL MIO INSULIN INFUSION SET