BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2962343 · Received February 14, 2013

    Report

    Report Number
    2032227-2013-00608
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED THAT HE WAS TREATED BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED BLOOD GLUCOSE LEVELS OF 64, 52 AND 49 MG/DL. THE CUSTOMER STATED THAT THE PARAMEDICS FELT THE INSULIN PUMP SETTINGS WERE NOT CORRECT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ALSO ACCURATE. THE CUSTOMER MENTIONED THAT HE MAY HAVE EXPOSED THE INSULIN PUMP TO HIGH MAGNETIC FIELDS DURING A MEDICAL PROCEDURE. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65331 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention