BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161767 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01667
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO INJURIES HE SUSTAINED IN A CAR ACCIDENT. THE CUSTOMER WAS DRIVING HIS TRUCK WHEN HE EXPERIENCED A LOW BLOOD GLUCOSE READING OF 47 MG/DL, CAUSING HIM TO FLIP HIS TRUCK OVER SEVERAL TIMES. THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR THE PAST MONTH. TROUBLESHOOTING WAS NOT POSSIBLE AT THE TIME OF THE CALL. IT WAS ALSO STATED THAT THE BATTERY CAP WAS STUCK, AND WAS UNABLE TO BE REMOVED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. 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