BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2091408 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81370
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY MULTIPLE TIMES. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 160 MG/DL. TROUBLESHOOTING WAS PERFORMED. HAD CUSTOMER TO RUN A FIXED PRIME TEST AND THE INSULIN PUMP ALARMED NO DELIVERY AGAIN. INSTRUCTED CUSTOMER TO CHANGE THE INFUSION SET WITH THE SAME RESERVOIR. THE CUSTOMER WAS ABLE TO PRIME MANUALLY. THE CUSTOMER ALSO STATED THAT WHILE RUNNING THE FIXED PRIME TEST THERE WAS NO INSULIN COMING OUT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR