BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3842392 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02677
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    July 1, 2004
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    THE CUSTOMER CALLED TO INQUIRE ABOUT NEW PRODUCT. DURING THE PHONE CALL, THE CUSTOMER'S BLOOD GLUCOSE READING WAS 36 MG/DL. THE CUSTOMER STATED THAT THEY TREATED THE LOW BLOOD GLUCOSE BY DRINKING TWO GLASSES OF ORANGE JUICE, EATING A PIECE OF WATERMELON AND HAVING BREAKFAST. THE CUSTOMER DECLINED TROUBLESHOOTING. DURING THE CALL THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED A COUPLE OF YEARS AGO DUE TO LOW BLOOD GLUCOSE READING OF 40 MG/DL. THE CUSTOMER PASSED OUT AND THE PARAMEDICS WERE CALLED BY THE SISTER IN LAW OF THE CUSTOMER. THE CUSTOMER STATED THAT THEY TOOK TWO SHOTS OF INSULIN INSTEAD OF ONE SHOT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320755 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention