BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070224 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00957
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS OF 547 MG/DL DURING A ROUTINE DOCTOR'S APPOINTMENT. THE CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS ELEVATED DUE TO A CHANGE IN THE BASAL RATE PROGRAMMING. 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 MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization