BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200354 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23840
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    CUSTOMER REPORTED HE WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 510 MG/DL, TREATED WITH BOLUS. CUSTOMER'S SYMPTOMS WERE IRRITABILITY AND URINATION. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. SIMILAR CALL FOR HIGH BLOOD GLUCOSE WAS (B)(6) 2013. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DISCONNECTED AT THE QUICK RELEASE. NO LEAKS OR AIR BUBBLES NOTED. MANUAL PRIME WAS PERFORMED ON THE DEVICE AND INSULIN DID EXIT. HIGH PRESSURE TEST WAS PERFORMED ON THE DEVICE AND INSULIN DID EXIT. HIGH PRESSURE TEST WAS PERFORMED ON THE DEVICE, PASSED. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE INFUSION SET, RESERVOIR, AND INSULIN. THE CANNULA OF THE INFUSION SET WAS BENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577280 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR