BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS

    MDR report key: 10909830 · Received November 26, 2020

    Report

    Report Number
    2032227-2020-210189
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    November 18, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    UDI-DI
    000000643169221505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS MORE THAN 500 MG/DL. CUSTOMER STATED THAT HE WAS UNSURE OF THE EXACT NUMBER AND HAD TO GET SYRINGE TO DEO MANUAL INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE DUE TO THE CAUSE BEING THE MOTOR ERROR ALERTS ON THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS NORMAL AND INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376497 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-723RNAS A000290012 000000643169221505

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other