BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082816 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81253
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 330MG/DL. THE CUSTOMER STATED THAT SHE GAVE HERSELF SEVERAL BOLUSES WITH THE BOLUS WIZARD. THE CUSTOMER STARTED VOMITING, HAD CHILLS AND ACHES. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SET EVERY THREE DAYS. THE PROGRAMMING, TIME, AND DATE ON THE DEVICE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TESTS. NO FURTHER INFO 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 54 YR Hospitalization (B)(4) INFUSION SET: MMT-921