BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2863247 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-91141
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 HAVING UNEXPLAINED LOW BLOOD GLUCOSE FOR TWO WEEKS AND BEING ADMITTED FOR MEDICAL TREATMENT. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 100MG/DL. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED TO HIS HOME DUE TO LOW BLOOD GLUCOSE. TROUBLESHOOTING COULD NOT BE PERFORMED AS CUSTOMER WAS DRIVING AT THE TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention