BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4155581 · Received October 9, 2014

    Report

    Report Number
    2032227-2014-26265
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER REQUESTED ASSISTANCE WITH HIS INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH PERFORMING 5 UNITS OF FIXED PRIME. THE CUSTOMER STATED INSULIN DID NOT EXIT. IT WAS FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING WITH A PLUNGER PUSH. THE CUSTOMER ALSO REPORTED RECEIVING A NO DELIVERY ALARM DURING A MANUAL PRIME. THE CUSTOMER WAS ADVISED HIS NO DELIVERY ALARM MAY BE CAUSED FROM AN INFUSION SET OR RESERVOIR OCCLUSION. TROUBLESHOOTING FOD NO DELIVERY COULD NOT BE CONTINUED AS THE CUSTOMER DID NOT HAVE ANY MORE INSULIN. CUSTOMER'S BLOOD GLUCOSE WAS 252 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635857 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR