BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2133684 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-81715
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 FOR HYPERGLYCEMIA, WITH BLOOD GLUCOSE OF 400 MG/DL. THE CUSTOMER STATED THAT HE HAD BEEN HAVING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS THE DAY BEFORE THE EVENT. THE CUSTOMER ALSO STATED THAT HE LAST CHANGED HIS INFUSION SET THE DAY OF THE EVENT IN AN ATTEMPT TO BRING DOWN HIS BLOOD GLUCOSE LEVELS. THE CUSTOMER THEN STATED THAT HE USES A SILHOUETTE INFUSION SET AND CHANGES HIS INFUSION SET EVERY THREE DAYS BUT THAT HE DOES NOT ALLOW THE INSULIN TO WARM FIRST. IT WAS EXPLAINED TO THE CUSTOMER THAT IT WAS IMPORTANT TO ALLOW THE INSULIN TO WARM BEFORE USE. 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-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization UNOMEDICAL SILHOUETTE INSULIN INFUSION SET| MODEL MMT-381, LOT 645742