BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2190363 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01835
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN THE WAY IT WAS SUPPOSED TO. THE CUSTOMER WENT TO HOSP, AND HIS BLOOD GLUCOSE READING WAS 458 MG/DL. THE CUSTOMER WAS TAKEN OFF OF INSULIN PUMP THERAPY, AND WAS TREATED BY THE HOSP STAFF. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T FEEL THAT ENOUGH INSULIN WAS EXITING. FOUND THAT THE CUSTOMER HAD NOT CHANGED THE INFUSION SET TO SOLVE THE ISSUE. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. 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-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization