BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2032348 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-80742
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 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 TWICE, ONCE DUE TO HYPERGLYCEMIA, THE SECOND TIME DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S NURSE EDUCATOR STATED THAT THEY TRIED A SET CHANGE TO RESOLVE THE ISSUE BUT FOUND A LEAKING RESERVOIR WHEN THEY REMOVED IT FROM THE INSULIN PUMP. THE CUSTOMER'S NURSE EDUCATOR STATED THAT THE CUSTOMER USED AN MMT-381 SILHOUETTE INFUSION SET. PROGRAMMING WAS REVIEWED AND TIME WAS FOUND TO BE OFF BY ONE HOUR. TROUBLESHOOTING WAS PERFORMED AND INSULIN WAS LEAKING FROM WHERE THE TUBING CONNECTS TO THE P-CAP DURING THE FIXED PRIME AND HIGH PRESSURE TEST. NOTHING FURTHER WAS TESTED.

    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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization MMT-381| UNOMEDICAL PARADIGM SILHOUETTE INFUSION SET