BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103480 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26402
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS RECEIVING NO DELIVERY ALARMS ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 494 MG/DL. THE CUSTOMER PERFORMED A 5.0 UNIT FIXED PRIME. THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER WAS ADVISED TO REMOVE THE INFUSION SET AND THE CANNULA WAS FOUND TO BE BENT. THE CUSTOMER STATED SHE DID NOT USE A SERTER DEVICE FOR INSERTION AND INSERTED MANUALLY. THE CUSTOMER'S INSERTION SITE WAS IN HER HIP. IT WAS ADVISED THIS IS NOT A RECOMMENDED LOCATION. IT WAS ADVISED THE NO DELIVERY ALARM MAY HAVE BEEN DUE TO THE BET CANNULA AND TO CHANGE THE ENTIRE INFUSION SET. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585261 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR UNOMEDICAL INSULIN INFUSION SET