BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2151564 · Received June 28, 2011

    Report

    Report Number
    3004209178-2011-81979
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2011-81980.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST TWO DAYS. THE CUSTOMER WAS CALLING FORM THE HOSPITAL, AND HAD A BLOOD GLUCOSE READING OF 359 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP FAILED THE PRIME TEST. THE CUSTOMER CHECKED FOR LEAKS, AND DID NOTICE INSULIN LEAKING. THE CUSTOMER DID NOT FEEL WELL ENOUGH TO CONTINUE TROUBLESHOOTING. 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 PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| (B)(4)