BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070251 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00942
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 4, 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 WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OVER 1000 MG/DL. FOUND THAT THE CUSTOMER USED AN INFUSION SET THAT SHE HAD NEVER USED BEFORE. IT WAS STATED THAT THE DOCTOR WAS NOT RELEASING THE CUSTOMER UNTIL SOMEONE CAME OUT TO THE HOSPITAL TO CONDUCT TROUBLESHOOTING IN PERSON. TROUBLESHOOTING OVER THE PHONE WAS DECLINED. 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-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization