BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161768 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01668
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2009-01414.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED BY THE CUSTOMER'S ATTORNEY'S OFFICE: ON (B)(6) 2009, THE CUSTOMER SUFFERED A HYPOGLYCEMIC EVENT WHILE DRIVING A VEHICLE, DUE TO AN ALLEGED DEFECT IN HIS INSULIN PUMP AND INFUSION SET. LAWSUIT FURTHER ALLEGES THAT THIS HYPOGLYCEMIC EVENT CAUSED THE CUSTOMER TO LOSE CONSCIOUSNESS AND VEER OFF THE ROAD INTO A TREE, ALLEGEDLY, CAUSING LASTING AND PERMANENT INJURIES TO THE CUSTOMER. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-396, LOT 8200956