BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4203854 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43736
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM DURING PRIME. IT WAS STATED THAT THE INFUSION SET HAS BEEN CHANGED SEVERAL TIMES. CUSTOMER WAS ADVISED TO DISCONNECT AND RECONNECT THE TUBING AND RESERVOIR AND PERFORM MANUAL PRIME; INSULIN DID EXIT THE TUBING. CUSTOMER INSTRUCTED TO REWIND THE INSULIN PUMP, REINSERT RESERVOIR AND RUN MANUAL PRIME; THE INSULIN PUMP DID NOT ALARM NO DELIVERY. BLOOD GLUCOSE VALUE IS 251 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684344 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR