BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212456 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-41336
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 BY THE CUSTOMER AND HIS WIFE THAT THE CUSTOMER HAD CHANGED THE INFUSION SET TODAY. CUSTOMER TRIED TO GIVE HIMSELF INSULIN AND FILLED IT WITH 200 UNITS, BUT WHEN HE CHECKED LATER, IT WAS AT 144 UNITS, CUSTOMER DID NOT SEE INSULIN DRIPPING ANYWHERE, BUT HIS BLOOD GLUCOSE LEVEL HAS BEEN REALLY HIGH. CUSTOMER HAD A FAILED SENSOR, BUT WAS USING A DEXCOM SENSOR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. CUSTOMER TOOK AN INJECTION AS TREATMENT. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN EXITED THE TUBING. ALARM HISTORY AND BOLUS HISTORY WERE REVIEWED. PUMP PASSED HIGH PRESSURE TEST. CUSTOMER FOUND THAT THE CANNULA WAS BENT BUT NOT OCCLUDED. CUSTOMER IS SENDING THE INFUSION SET BACK FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680762 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR