BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210661 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43306
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS. IT WAS ALSO STATED CUSTOMER HAS RECEIVED NO DELIVERY ALARMS. BLOOD GLUCOSE AT THE TIME OF THE ADMISSION WAS 455 MG/DL; CURRENT LEVEL 350 MG/DL. IT WAS STATED THAT THE CUSTOMER HAD HIGH KETONES, HIGH POTASSIUM LEVELS AND MAY HAVE HAD A HEART ATTACK. CUSTOMER WAS IN THE INTENSIVE CARE UNIT. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. THE TUBING HAS NO AIR BUBBLES AND NO INSULIN LEAK WAS FOUND. CUSTOMER WAS ABLE TO REWIND AND PERFORM MANUAL PRIME. TIME, DATE AND BASAL RATES ARE SET UP CORRECTLY. INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680680 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization