BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2243576 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82839
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 TO CHEST PAIN AND HIGH BLOOD GLUCOSE OF 485 MG/DL. IT WAS STATED THAT THE EVENTS LEADING TO HER ADMISSION WAS FATIGUE. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST WEEK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 162 MG/DL, AND SHE WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HER BASAL RATE WAS 1.15 UNITS AND SHOULD BE 1.30 UNITS. THE CUSTOMER REQUESTED ASSISTANCE IN CHANGING HER BASAL RATE. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization