BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123177 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-25975
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTER. THE DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP KEPT GOING INTO REWIND LOOP AND WAS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER'S BLOOD GLUCOSE WAS 149 MG/DL. CUSTOMER REPORTED THE NUMBER APPEARED ON THE SCREEN WHEN ASKED TO HOLD THE ACT BUTTON. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. CUSTOMER REQUESTED THE DEVICE TO BE REPLACED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602427 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR