BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5857320 · Received August 9, 2016

    Report

    Report Number
    3004209178-2016-65892
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 18, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED VIA PHONE CALL OF HOSPITALIZATION FOR HIGH BLOOD GLUCOSE OF 600MG/DL. TROUBLESHOOTING FOUND THAT THE CUSTOMER HAS ISSUES CALIBRATING AND THAT SOMETIMES THE CANNULAS ARE BENT. CUSTOMER ALSO INDICATED THAT SENSOR GLUCOSE DEOS NOT MATCH THE BLOOD GLUCOSE. TROUBLESHOOTING ADVISED CUSTOMER ON PROPER CALIBRATION POSSIBLE REASONS FOR THE SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCES. THE CUSTOMER WAS ADVISED TO CALL BACK IF FURTHER ASSISTANCE IS NEEDED AS IT APPEARS THAT THE PUMP IS OPERATING AS DESIGNED. THE CUSTOMER WAS ADVISED TO FOLLOW UP WITH THEIR DOCTOR REGARDING THE HIGH BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508723 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O