BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2140436 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-81824
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 827MG/DL. IT WAS STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. IT WAS STATED THAT THE BATTERY WAS CHANGED THE NIGHT BEFORE THE EVENT AND THE INSULIN PUMP ALARMED SEVERAL TIMES. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 276MG/DL. ATTEMPTED TO HAVE THE MOTHER TO REWIND THE INSULIN PUMP, BUT THE SCREEN WENT BLANK. ADVISED THE MOTHER TO DISCONTINUE USE OF THE INSULIN PUMP UNTIL THE REPLACEMENT OF THE DEVICE ARRIVES. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization