BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH

    MDR report key: 4142344 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33712
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). 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 THE INSULIN PUMP HAD MULTIPLE ALARMS. ALARMS AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. CUSTOMER DID NOT KNOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS DISCONNECTED FROM THE DEVICE. UNABLE TO FINISH TROUBLESHOOTING THE CALL WAS DROPPED AND NO RESPONDS WHEN CUSTOMER WAS CALLED. CUSTOMER HAD INCORRECT AMOUNT OF INSULIN SAVED INTO THE DEVICE. CUSTOMER WAS HAVING PROBLEMS WITH FILLING THE CANNULA. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622028 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR