BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142275 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33391
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT THE CUSTOMER GOT A NO DELIVERY ALARM ON AN INFUSION SET THAT HAD BEEN IN FOR 2 DAYS. CUSTOMER RECEIVED THE ALARM IN THE MIDDLE OF THE NIGHT AND CHANGED THE WHOLE INFUSION SET OUT. CUSTOMER WAS STILL GETTING A NO DELIVERY ALARM DURING A BOLUS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 540 MG/DL. CUSTOMER WAS ONLY TRYING TO CORRECT THROUGH THE PUMP AND DOES NOT HAVE ANY OTHER OPTION. CUSTOMER WAS NOT ABLE TO TROUBLESHOOT BECAUSE HE DID NOT HAVE HIS SUPPLY WITH HIM. CUSTOMER WILL BE GOING HOME AND WILL CHANGE HIS INFUSION SET SYSTEM. CUSTOMER STATED THAT HIS BODY HAS CHANGED RECENTLY AND HAS LOST WEIGHT. IT WAS EXPLAINED THAT THE MORE NO DELIVERIES HE GETS, THE MORE HE NEEDS TO CONSIDER THE CHANGES IN HIS BODY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622065 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR