BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2233949 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82789
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 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
    MO, 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 PROD 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 HIGH BLOOD GLUCOSE AND HEART ISSUES. THE BLOOD GLUCOSE READDING WAS 200 MG/DL. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST HOURS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 60 MG/DL, AND SHE HAS TREATED WITH FOOD. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND THE TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST AT TIME OF CALL. THE CUSTOMER STATED THAT SHE DOES NOT NOTICE BENT CANNULAS OFTEN. THE CUSTOMER USES THE RESERVOIRS FOR FIVE DAYS. 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-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization QUICK SET: 23| UNOMEDICAL INFUSION SET: MMT-397| PARADIGM: 9MM CATHETER