BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 10956711 · Received December 7, 2020

    Report

    Report Number
    2032227-2020-213529
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 7, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS WRITTEN IN ERROR AS IT IS A DUPLICATE TO MDR NUMBER 2032227-2020-213853.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS ON (B)(6) 2020. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 512 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 126 MG/DL. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUID AND INSULIN FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE AUTO MODE FEATURE WAS NOT ACTIVE AT TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT RETAINER RING CAME OFF. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423172 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization FRN-UNK-RSVR, UNOMED SET