BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8116496 · Received November 29, 2018

    Report

    Report Number
    2032227-2018-68738
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 18, 2018
    Report Date
    November 29, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. CUSTOMER DID NOT PROVIDE ANY SYMPTOMS AND TREATMENT RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR. UNOMED INF SET. OZO-MMT-7020A-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957104 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 47 YR Other FRN-UNK-RSVRUNOMED INF SETMMT-7020A