BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2870132 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-08021
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    IT WAS REPORTED THAT THE CUSTOMER WENT ON THE INSULIN PUMP OVER A WEEK AGO, AND SHE WAS BROUGHT IN THE HOSPITAL THE DAY AFTER THANKSGIVING. IT WAS STATED THAT THE MOTHER WOULD LIKE TO HAVE AN ANALYSIS ON THE INSULIN PUMP TO BE SURE THE INSULIN PUMP WAS DOING WHAT IT SUPPOSED TO DO. DAYS LATER IT WAS REPORTED VIA E-MAIL THAT THE CUSTOMER PASSED AWAY, AND SHE WAS NOT WEARING THE INSULIN PUMP AT TIME OF DEATH. IT WAS STATED THAT THE CUSTOMER MAY HAVE HAD THE FLU OR EVEN FOOD POISONING AS OTHER FAMILY MEMBERS WERE ILL. IT WAS STATED THAT THE CAUSE OF DEATH WAS ANOXIA, WHICH CAUSED THE BRAIN DEATH. IT WAS STATED THAT THE LAST BLOOD GLUCOSE RECORDED IN THE BLOOD GLUCOSE METER OR IN THE INSULIN PUMP WAS 423 MG/DL. IT WAS STATED THAT SEVERAL ATTEMPTS WERE DONE TO UPLOAD THE INSULIN PUMP INTO THE CARELINK PERSONAL AND AFTER SEVERAL ATTEMPTS IT KEEPS STOPPING AT 90%. ASSISTED WITH REVIEWING THE DEVICE ALARM HISTORY AND NO ALARMS FOUND. NO FURTHER INFORMATION WAS PROVIDED.

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS UNKNOWN. CALLER STATED THAT THE CUSTOMER HAD THE FLU OR POSSIBLE VIRAL MENINGITIS. THE CUSTOMER EXPERIENCED SEVERELY LOW SODIUM LEVELS WHICH HAS SINCE CAUSED BRAIN DAMAGE. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death| H