BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3041687 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92417
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    October 30, 2012
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED TWICE DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 1400MG/DL. THE CUSTOMER STATED THAT SHE WAS UNCONSCIOUS WHEN HER SON FOUND HER AND CALLED THE PARAMEDICS. THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND SHE WAS IN A COMA FOR FIVE DAYS BEFORE SHE WOKE UP. TROUBLESHOOTING COULD NOT BE PERFORMED AS CUSTOMER STATED THAT SHE IS RELEARNING HOW TO USE HER ARMS AND LEGS. THE CUSTOMER REQUESTED HAVING THE DEVICE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142970 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 51 YR Hospitalization