BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6144894 · Received December 5, 2016

    Report

    Report Number
    2032227-2016-47221
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(6) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER'S SPOUSE REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 545 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 329 MG/DL AT THE TIME OF CALL. THE CUSTOMER'S SPOUSE STATED THAT THEY WERE VOMITING. THE CUSTOMER'S SPOUSE STATED THAT THEY WERE GIVEN INSULIN TO TREAT THE BLOOD GLUCOSE. THE CUSTOMER'S SPOUSE STATED THAT THEY WERE WEARING THE INSULIN PUMP DURING HOSPITALIZATION. THE CUSTOMER'S SPOUSE STATED THAT THEY FOUND THAT THE TIME AND DATE WAS PROGRAMMED WAS INCORRECT DURING TROUBLESHOOTING. THE CUSTOMER'S SPOUSE ALSO REPORTED THAT THEY WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795176 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization