BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8172485 · Received December 17, 2018

    Report

    Report Number
    2032227-2018-76035
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 17, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HYPERGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 450 MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP GIVES THE INSULIN FLOW BLOCK ALARM. THE CUSTOMER STATED THAT THEY ARE NOT ABLE TO TROUBLESHOOT AT CALL. CUSTOMER REPORTS ALARM DID NOT OCCUR DURING FILL TUBING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008562 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 46 YR Other FRN-UNK-RSVR UNOMED SET