BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920051 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86498
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HIS INSULIN PUMP WAS ALARMING NO DELIVERY WHEN HE WAS ATTEMPTING TO PRIME AND UPON INQUIRING FURTHER, IT WAS DISCOVERED THAT HE HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. CUSTOMER STATED HE HAD GOTTEN OUT OF BED AND FALLEN. CUSTOMER'S SPOUSE TREATED LOW BLOOD GLUCOSE WITH APPLE JUICE AND SUGAR UNTIL PARAMEDICS COULD ARRIVE. PARAMEDICS RESPONDED TO CUSTOMER'S HOME AND BLOOD GLUCOSE LEVEL WAS 30 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING DEVICE DUE TO EXPERIENCE. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO HEALTHCARE PROVIDER'S INSTRUCTIONS WHILE REPLACEMENT WOULD BE SENT. BLOOD GLUCOSE LEVEL WAS 116 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396607 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization