BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8543592 · Received April 24, 2019

    Report

    Report Number
    2032227-2019-03441
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 15, 2019
    Report Date
    April 24, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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

    IT WAS REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 24.1 MMOL/L AT THE TIME OF INCIDENT. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS AND TREATMENT OF HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. CUSTOMER ALSO STATES THAT THE INSULIN PUMP THE AREA WHERE CUSTOMER LOCKS THE BATTERY CAP IT HAD A PIECE MISSING AND ALSO STATES THE METAL PIECE ON THE BATTERY CAP CAME OFF. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339599 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 Other FRN-UNK-RSVR, UNOMED SET.