BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB

    MDR report key: 8784018 · Received July 12, 2019

    Report

    Report Number
    2032227-2019-28999
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA. CUSTOMER PERFORMED SELF-TEST AND IT PASSED. CUSTOMER CALLED REGARDING NO DELIVERY. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577330 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB B4523NABJ 00643169507166

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other FRN-UNK-RSVR, UNOMED INF SET