BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9794473 · Received March 5, 2020

    Report

    Report Number
    2032227-2020-101624
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    January 29, 2020
    Report Date
    April 13, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION GIVEN RELATED TO PRO CODE WAS INCORRECT WITH THE INITIAL REPORT. THE CORRECT INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 54 MG/DL BUT AFTER A FEW MINUTES BLOOD GLUCOSE WAS OVER 51 MG/DL. CUSTOMER HAS TREATED THE LOW READING AND DECLINED TROUBLESHOOTING. CUSTOMER ALSO STATED THERE WAS BLEEDING AT SENSOR INSERTION SITE. WHEN CUSTOMER SEES LARGE DIFFERENCES BETWEEN THEIR READINGS OR SEES A CALIBRATION NOT ACCEPTED ALERT, THEY WILL EXIT AUTO MODE AND WILL STAY IN MANUAL MODE FOR AN HOUR OR SO AND THEN RESUME TO SEE IF THE SENSOR CAN BE SAVED. ADVISED CUSTOMER THAT THE ISIG READINGS MIGHT NEED SOME TIME TO STABILIZE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258695 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other