BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2170656 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01686
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST (B)(6). TROUBLESHOOTING WAS PERFORMED AND THE CALLER STATED THAT THE PROGRAMMING APPEARED TO BE CORRECT, BUT SHE COULD NOT VERIFY IT BECAUSE, THE CUSTOMER WAS SUPPOSED TO BE SELF MONITORING HIS SETTINGS. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CALLER DIDN'T HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. FURTHER TROUBLESHOOTING COULD NOT BE CONDUCTED. THE CALLER STATED THAT THE CUSTOMER DID NOT WANT TO BE KEPT IN THE HOSPITAL, AND DECIDED TO LEAVE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization