BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2170705 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82147
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 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 DUE TO HIGH BLOOD GLUCOSE OF 600MG/DL. THE CUSTOMER WAS IN A VEHICULAR ACCIDENT. THE CUSTOMER ALSO REPORTED HAVING A STOMACH VIRUS AND SINUSITIS WHICH HAVE CAUSED HER HIGH BLOOD GLUCOSE. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR (B)(6) AND WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TEST. THE CUSTOMER STATED THAT SHE NOTICED THE CANNULAS WERE BENT WHILE CHANGING THE SITES AT HOME AND AT THE HOSPITAL. 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 28 YR Hospitalization (B)(4) INFUSION SET: MMT-397| QUICK-SET: 23| PARADIGM: 9MM CATHETER