BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130877 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94068
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF LESS THAN 21MG/DL. THE CALLER STATED THAT HE WOKE WITH LOW GLUCOSE OF 54MG/DL AND HE SUSPENDED THE INSULIN PUMP. THEN THE CUSTOMER ATE TWO BOWLS OF CEREAL AND HALF BOWL OF SUGAR, BUT HIS BLOOD GLUCOSE CONTINUED DROPPING. THE CUSTOMER STATED THAT THE DOCTOR BELIEVES THE INSULIN PUMP'S SETTINGS WERE TOO HIGH. ADVISED TO SPEAK TO HIS DOCTOR REGARDING HIS SETTINGS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231397 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 47 YR Hospitalization