BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6104111 · Received November 15, 2016

    Report

    Report Number
    2032227-2016-42187
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 23, 2016
    Report Date
    October 23, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    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)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVER RECEIVED A CALIBRATION ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 525 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR CALIBRATION ERROR ALARM. CUSTOMER WAS ADVISED TO MONITOR ISSUE AND CALL BACK SHOULD ISSUE PERSIST. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE DUE TO IT BEING NEARLY TIME TO CHANGE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753445 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other