BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4100799 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23749
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIMING. THE CUSTOMER'S BLOOD GLUCOSE WAS 487 MG/DL. THE CUSTOMER STATED THAT AFTER LUNCH THEIR BLOOD GLUCOSE WAS ABOVE 300 MG/DL, SO THE CUSTOMER TREATED WITH MANUAL INJECTION AND DECIDED TO CHANGE THEIR INFUSION SET. TROUBLESHOOTING WAS PERFORMED AND EVERYTHING TESTED WITHIN SPECIFICATION. THE ALARM WAS CLEARED. THE CUSTOMER DID NOT WANT TO PERFORM TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE, STATING THAT THEY TRUST THEIR INSULIN PUMP. THE CUSTOMER STATED THAT THE CANNULA OF THE INFUSION SET WAS NOT BENT. THE CUSTOMER STATED THAT THEY TREATED FIVE UNITS OF MANUAL INJECTION AND A BOLUS FROM THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571866 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention