BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6148641 · Received December 6, 2016

    Report

    Report Number
    2032227-2016-47445
    Event Type
    Death
    Date Received
    December 6, 2016
    Date of Event
    October 15, 2016
    Report Date
    March 15, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DELIVERY ACCURACY TEST. THE PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP. DATA ANALYSIS: THERE IS NO DATA AVAILABLE DUE TO THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED.

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN THE MIDDLE OF THE NIGHT, IN HIS SLEEP. THE TROOPERS FOUND THE CUSTOMER THE NEXT MORNING. THE CALLER STATED THAT THE CUSTOMER WAS NOT FEELING VERY WELL AND WENT TO BED. THE CAUSE OF DEATH WAS JUVENILE DIABETES AND HYPERTENSION. THE CALLER STATED THAT THE CUSTOMER HAD BEEN FEELING SICK SINCE HE CHANGED STATES; HAD EYE INFECTION AND PNEUMONIA. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798623 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death