BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103234 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26489
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST MONTH. THE BLOOD GLUCOSE READING WAS 597 MG/DL ON THE MORNING OF THE CALL. THE MOST RECENT BLOOD GLUCOSE READING WAS 510 MG/DL, WHICH THE CUSTOMER TREATED WITH THE INSULIN PUMP. UPON TROUBLESHOOTING, IT WAS FOUND THAT INSULIN DID EXIT THE TUBING DURING A MANUAL PRIME, AND NO LEAK WAS OBSERVED. UNABLE TO COMPLETE TROUBLESHOOTING DUE TO LACK OF A TUBING CLAMP. THE CANNULA WAS NOT BENT. EXPLAINED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY INSERTION SITE OR INFUSION SET ISSUES. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582168 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR