BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5974678 · Received September 23, 2016

    Report

    Report Number
    2032227-2016-23323
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    August 29, 2016
    Report Date
    September 1, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL. CUSTOMER WAS WEARING THE DEVICE AT TIME OF HOSPITALIZATION. DURING TROUBLESHOOTING, DEVICE PASSED THE SELF TEST. CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626016 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization