BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241204 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50025
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 EXPERIENCED HIGH BLOOD GLUCOSE OF 469 MG/DL; CUSTOMER TREATED WITH BOLUS DOSE. IT WAS STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. THE TUBING HAS NO AIR BUBBLES AND NO INSULIN LEAK WAS FOUND. INSULIN DID EXIT THE TUBING WITH MANUAL PRIME. TIME AND DATE ARE CORRECT. CUSTOMER WAS UNSURE IF THE BASAL RATES ARE CORRECT AND BOLUS WIZARD SETTINGS ARE UNKNOWN. CUSTOMER'S MOTHER DECLINED TO CONTINUE TROUBLESHOOT AS SHE WANTED TO CHANGE THE INFUSION SET AND RESERVOIR. IT WAS STATED THAT ONE SITE FELL OUT AND ALSO CUSTOMER WAS HAVING SOME BRUISING ON HER LEG. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724015 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH A9523NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention