BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4100849 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23449
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OF OVER 500 MG/DL, SINCE THE DAY PRIOR TO THE PHONE CALL, WHEN THEY CHANGED THE INFUSION SET. THE CUSTOMER HAD CHANGED THE INFUSION SET TWICE, THE DAY PRIOR TO THE PHONE CALL. THE CUSTOMER STATED THAT THEY WERE LAZY AND SLEEPY. THE CUSTOMER HAD TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED AND EVERYTHING TESTED WITHIN SPECIFICATION. THE HIGH PRESSURE TESTED PASSED. THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS RECESSED. IN THE ALARM HISTORY THERE WAS LOW RESERVOIR ALERT PRESENT. THE CANNULA OF THE INFUSION SET WAS NEITHER BENT NOR OCCLUDED. THE CUSTOMER STATED THAT THEY INSERT THE INFUSION SET IN THEIR THIGH, HALF WAY DOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572105 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 139 YR Required Intervention