BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2020699 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00571
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER WAS ALSO SUFFERING FROM A URINARY TRACT INFECTION. WHILE AT THE HOSPITAL, THE CUSTOMER UNDERWENT A SURGERY UNRELATED TO DIABETES. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 436 MG/DL AT THIS TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. NO INFUSION SET OR SITE PROBLEMS WERE NOTED. THE CUSTOMER USES QUICK-SET INFUSION SETS, MODEL NUMBER MMT-397. THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER WAS SENT A TUBING CLAMP AND ADVISED TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST. 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 20 YR Hospitalization