BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4926631 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-76440
    Event Type
    Death
    Date Received
    July 20, 2015
    Date of Event
    June 28, 2015
    Report Date
    February 6, 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

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DISPLACEMENT ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP RECEIVED WITH MAX FORCE ALKALINE BATTERY. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHED LCD WINDOW. DATA ANALYSIS THE INSULIN PUMP ALARMED BATTERY OUT LIMIT (B)(4) 2015 5:03PM. HOWEVER, CUSTOMERS CHANGE THE TIME AND DATE TO (B)(4) 2012 6:45PM. DAILY TOTALS = 0.00U FROM (B)(4) 2012.

    Description of Event or Problem · 1

    THE HUSBAND REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2015 IN A HOSPITAL. THE OFFICIAL CAUSE OF DEATH WAS FROM DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CALLER REPORTED THE CUSTOMER WAS HOSPITALIZED STARTING ON (B)(6) 2015 FROM BREAKING THEIR PELVIS. IT WAS ALSO REPORTED THE CUSTOMER WAS UNABLE TO UTILIZE THE BLOOD GLUCOSE METER, WHICH CAUSED THEIR BLOOD GLUCOSE TO SPIRAL OUT OF CONTROL AND LED TO THEIR DEATH. THE CALLER ALSO REPORTED THE CUSTOMER HAD KIDNEY FAILURE, HEART DISEASE, A STROKE AND DIABETES COMPLICATIONS BEFORE PASSING. IT WAS ALSO REPORTED THE CUSTOMER DID NOT USE SENSORS AND WAS NOT WEARING ONE AT THE TIME OF DEATH. THE CALLER ALSO REPORTED THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH DUE TO THE HOSPITALIZATION. THE INSULIN PUMP WAS REMOVED BY EMERGENCY WORKERS FOR AN UNKNOWN PERIOD OF TIME BEFORE THE CUSTOMER PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469630 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 70 YR Death