BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2190406 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01843
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THE NUMBERS SCROLLING UP AUTOMATICALLY WHILE TRYING TO PROGRAM A BOLUS. THE BATTERY WAS CHANGED, AND THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. THE ALARM COULD NOT BE CLEARED DUE TO UNRESPONSIVE BUTTONS. THE CUSTOMER WAS CALLING FROM THE HOSP WHERE HE WAS TAKEN DUE TO A LOW BLOOD GLUCOSE READING OF 5 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS 500 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization