BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193367 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01864
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. 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 THE PARAMEDICS WERE CALLED AFTER BEING INVOLVED IN A CAR ACCIDENT. THE CUSTOMER STATED THAT HE WAS DRIVING, AND BLACKED OUT DUE TO HIGH BLOOD GLUCOSE LEVELS AND POSSIBLE DEHYDRATION. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 464 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER'S BASAL RATE AND BOLUS WIZARD SETTINGS WERE NOT CORRECT. THE CUSTOMER HAD A PAPER WITH THE CORRECT BOLUS SETTINGS, BUT SHE WAS STILL UNSURE. ADVISED THE CUSTOMER TO SPEAK WITH HER HEALTHCARE PROFESSIONAL TO GET THE CORRECT SETTINGS. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. 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 68 YR Hospitalization