BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123411 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29657
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    CUSTOMER REPORTED, SHE DELIVERED INSULIN INCORRECTLY DUE TO THE SCROLL WRAP ISSUE. SHE ALSO STATED, SHE HAS HAD SOME LOW BLOOD GLUCOSE LEVELS ON AND OFF FOR THE LAST MONTH. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 256 MG/DL. THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER USES PROPER PRIMING METHODS. THE PROGRAMMING IS CORRECT. CUSTOMER STATED, THE RESERVOIR HAS MORE INSULIN THAN THE INSULIN PUMP IS SHOWING ON THE SCREEN. THE DEVICE PASSED THE DISPLACEMENT TEST. CUSTOMER WAS ADVISED TO MONITOR HIS BLOOD GLUCOSE AND SPEAK TO HIS DOCTOR ABOUT HIS LOWS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600311 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR