BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2021247 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00559
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 429 MG/DL AT THE TIME OF THE REPORT. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS HIGH DUE TO SEVERAL BLOOD INFECTIONS, AND THE EVENT DID NOT SEEM TO BE RELATED TO THE INSULIN PUMP. AT THE TIME OF THE REPORT, THE INSULIN PUMP ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE PRIME TEST PASSED. THE CUSTOMER USES SILHOUETTE INFUSION SETS, MODEL NUMBER MMT-378. 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 MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization