BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3041727 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92412
    Event Type
    Death
    Date Received
    April 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. IT WAS STATED THAT THE LAST TIME THEY CHECKED HIS BLOOD GLUCOSE, IT WAS 57MG/DL IN THE EARLY MORNING HOURS. IT WAS STATED THAT THE CUSTOMER HAD BAD HEART BURN AND A BAD HEART. THE WIFE STATED THAT AROUND 7:30AM HE WAS THROWING UP AND TWO HOURS LATER HE WAS THROWING UP BLOOD. HIS HEART COULDN'T TAKE AND THE PARAMEDICS WERE CALLED. IT WAS STATED THAT THE INSULIN PUMP WAS SUSPENDED BECAUSE OF THE LOW BLOOD GLUCOSE MEASURED AT 3:30AM. THE WIFE AGREES TO RETURN THE INSULIN PUMP FOR FURTHER ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143107 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death