BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171122 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82115
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE HYPERGLYCEMIA. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS TREATED AT THE HOSPITAL WITH AN INSULIN DRIP AND MANUAL INJECTIONS. THE CUSTOMER ALSO REPORTED HAVING A HEMATOMA TWO WEEKS AGO UNDER HIS SITE, AND AFTER REMOVAL HE WAS TAKING ANTIBIOTICS. THE CUSTOMER STATED THAT WHEN HE HAD HIGH BLOOD GLUCOSE, HE SAW THAT THE CANNULA WAS BENT. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization QUICK-SET, 23| PARADIGM, 6MM CATHETER| (B)(4) INFUSION SET: MMT-399