BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2193374 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01882
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 15, 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 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER EXPERIENCED VOMITING AND DIZZINESS PRIOR TO THE EVENT. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST WEEK. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CALLER DIDN'T HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. ADVISED THE CALLER THAT THE TUBING CLAMP WOULD BE SHIPPED TO HER. 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-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization