BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945904 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04760
    Event Type
    Death
    Date Received
    July 21, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    THIS INFORMATION IS PROVIDED IN RESPONSE TO YOUR REQUEST DATED (B)(4) 2014 FOR ADDITIONAL INFORMATION. NO INFORMATION WAS GIVEN WHY THE INSULIN PUMP WAS SUSPENDED FOR 7 DAYS. (B)(4) 2014 IS THE CORRECT DATE OF DEATH. CUSTOMER WAS IN COMA ON (B)(6) 2014, CUSTOMER WAS FOUND IN HIS CAR. CUSTOMER HAD JUST SEEN HIS PHYSICIAN REGARDING INSULIN.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE SPOUSE OF THE CUSTOMER CALLED IN TO REPORT THAT THE CUSTOMER HAS PASSED AWAY. THE DATE OF THE DEATH WAS 07/14/2014. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. BLOOD GLUCOSE READING AT THE TIME OF DEATH WAS BELOW 20 MG/DL. THE CAUSE OF THE DEATH WAS DETERMINED TO BE BRAIN DAMAGE FROM LACK OF OXYGEN AFTER THE CUSTOMER WENT INTO A COMA. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426152 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death