BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8657448 · Received May 31, 2019

    Report

    Report Number
    2032227-2019-09834
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 19, 2019
    Report Date
    May 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE, DIABETES KETOACIDOSIS AND HEART ATTACK ON (B)(6) 2019 AT 8 PM WITH THE BLOOD GLUCOSE OF 577 MG/DL. THE CUSTOMER'S OTHER BLOOD GLUCOSE WAS 360, 260, 230, 265, 233 MG/DL. THE CUSTOMER WAS TREATED WITH THE INSULIN DRIP. THE CUSTOMER STATED THAT THERE WAS NO DELIVERY ALARM. THE TROUBLESHOOTING WAS PERFORMED FOR THE HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER STATED THAT THEY HAD PERFORMED THE SELF TEST AND TEST WAS PASSED. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450417 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS B4523NASJ 00643169507203

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization FRN-MMT-326-RSVR, UNOMEDICAL SET