BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234005 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82782
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 HIGH BLOOD GLUCOSE OF OVER 500 MG/DL. THE CUSTOMER STATED THAT THE EVENTS LEADING TO HIS ADMISSION WAS SEVERE DEHYDRATION. THE CUSTOMER HAS BEEN WORKING OUTSIDE AND HIS GLUCOSE LEVEL WAS RUNNING HIGH. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 251 MG/DL, AND HE HAS TREATED WITH MANUAL INJECTIONS. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND THE TEST PASSED. THE CUSTOMER STATED THAT SHE STILL IS USING ANTIBIOTICS, WHICH MAY HAVE CAUSED HIS GLUCOSE LEVEL TO RISE. THE CUSTOMER STATED THAT HE HAS BEEN CHANGING THE INFUSION SETS VERY OFTEN. THE CUSTOMER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND THE TEST PASSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization QUICK SET, 23| UNOMEDICAL INFUSION SET, MMT-397| PARADIGM, 9MM CATHETER