BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2922780 · Received January 18, 2013

    Report

    Report Number
    2032227-2013-00226
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    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 NON-DIABETES RELATED ISSUE. CALLER STATED THAT WHILE THE CUSTOMER WAS IN THE HOSPITAL SHE DEVELOPED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 300 MG/DL. CALLER STATED THAT THE CUSTOMER WAS WEARING THE INFUSION SET FOR LONGER THAN THREE DAYS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27917 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization