BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC

    MDR report key: 8860301 · Received August 5, 2019

    Report

    Report Number
    2032227-2019-41301
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 5, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 440 MG/DL. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED. IT WAS REPORTED THA THEY WERE ASSISTED IN PERFORMING A 5.0 UNIT FIXED PRIME. CUSTOMER STATED THAT THE INSULIN EXITED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653268 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other FRN-UNK-RSVR, UNOMED INF SET