BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972263 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88777
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE CALLER STATED THAT THEY ARE DRIVING HOME AND THAT THEY ARE NOT WITH THE CUSTOMER OR THE INSULIN PUMP AT THE TIME OF THE CALL. THEY ALSO STATED THAT THEY WERE NOT WITH THE CUSTOMER WHEN THE ALARM OCCURRED. THE CUSTOMER'S LAST KNOWN BLOOD GLUCOSE WAS 280 MG/DL EARLIER DURING THE DAY OF THE PHONE CALL. NO TROUBLESHOOTING WAS DONE SINCE THE CALLER WAS NOT WITH THE CUSTOMER OR THE INSULIN PUMP. THE CALLER STATED THAT THEY ADVISED THE CUSTOMER TO CHANGE THEIR INFUSION SET AND THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447725 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR