BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6114680 · Received November 18, 2016

    Report

    Report Number
    2032227-2016-43079
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS BLOOD GLUCOSE WAS 300 MG/DL AT THE TIME OF CALL AND 400 MG/DL YESTERDAY; THE INSULIN PUMP ALARMED NO DELIVERY. THE PATIENT COULD NOT CURRENTLY TREAT WITH THE INSULIN PUMP. DURING TROUBLESHOOTING THE INSULIN PUMP DID NOT HAVE ANY ANOMALIES. HOWEVER, WHEN THE SET WAS REMOVED THE SITE BLED. THE PATIENT WAS ABLE TO PRIME THE TUBING, THOUGH. THE CUSTOMER WAS ADVISED OF A POSSIBLE SITE OCCLUSION. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763449 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other