BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4853268 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-66508
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 30, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 SHE WAS RECENTLY HOSPITALIZED FOR 4 DAYS. CUSTOMER'S BLOOD GLUCOSE HAD BEEN RUNNING IN THE LOW 300'S MG/DL BEFORE SHE WAS ADMITTED. CUSTOMER CHANGED HER SET AND SHE WENT TO SLEEP. CUSTOMER WOKE UP WITH BLOOD GLUCOSE IN THE 500'S MG/DL. CUSTOMER'S BLOOD GLUCOSE WAS 520 MG/DL WHEN SHE LEFT FOR THE HOSPITAL. CUSTOMER WAS GIVEN ANTIBIOTICS FOR A POSSIBLE BLADDER INFECTION BUT IT WAS FOUND THAT THERE WAS NO INFECTION. CUSTOMER'S DOCTORS BELIEVE SHE HAD A DEFECTIVE SET OR CANNULA. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 550 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 71 MG/DL. CUSTOMER WAS VOMITING, DEHYDRATED, AND TIRED. CUSTOMER HAD DIABETIC KETOACIDOSIS DUE TO A BLADDER INFECTION. CUSTOMER WAS OFF AND ON THE DEVICE DURING THE HOSPITAL STAY. CUSTOMER STATED THAT SHE BELIEVES THE SETS WERE NOT THE CAUSE OF THE HIGH BLOOD GLUCOSE. CUSTOMER IS NEW TO THE PUMP AND HAS BEEN ADJUSTING THE DEVICE FREQUENTLY. CUSTOMER DECLINED TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397304 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization