BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171123 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01704
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 28, 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 LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 164 MG/DL AFTER BEING TREATED BY THE PARAMEDICS. IT WAS STATED THAT THE CUSTOMER WENT FISHING (B)(6) PRIOR TO BEING HOSPITALIZED. THE CUSTOMER WAS SOAKED, BUT THE INSULIN PUMP WAS NEVER SUBMERGED IN WATER. (B)(6), THE CUSTOMER WAS FOUND UNCONSCIOUS BY HIS FAMILY. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP WHEN HE WAS FOUND. DURING THE CALL, A BATTERY WAS INSERTED, AND THE INSULIN PUMP ALARMED BUTTON ERROR. IT WAS STATED THAT THE CUSTOMER MAY HAVE RECEIVED THE SAME ALARM PRIOR TO LOSING CONSCIOUSNESS, CAUSING HIM TO STOP INSULIN PUMP THERAPY, AND GIVE HIMSELF MANUAL INJECTIONS. ADVISED THE CALLER 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization