BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5040347 · Received August 28, 2015

    Report

    Report Number
    2032227-2015-38285
    Event Type
    Death
    Date Received
    August 28, 2015
    Date of Event
    July 10, 2015
    Report Date
    February 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. AN UNEXPECTED RESTART ALARMED AFTER BATTERY CHANGE NOTED. THE INSULIN PUMP WAS UNABLE TO DETERMINE ROOT CAUSE OF THE ALARM AFTER BATTERY CHANGE DUE TO PRESERVATION. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. UNABLE TO PERFORM DATA ANALYSIS DUE TO NO HISTORY AVAILABLE ON HISTORY DOWNLOAD. NO DATA WAS AVAILABLE DUE TO INSULIN PUMP BEING RECEIVED WITHOUT BATTERY IN THE BATTERY TUBE.

    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

    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

    THE MEDICAL EXAMINER CALLED TO REPORT THE DEATH OF A CUSTOMER. THE CUSTOMER PASSED AWAY AT HOME. NO OFFICIAL CAUSE OF DEATH IS YET KNOWN. THE CALLER JUST KNOWS THAT THE CUSTOMER WAS FOUND AND HER BLOOD GLUCOSE WAS 37 MG/DL WHEN IT WAS CHECKED ON THE SCENE, AT THE TIME OF DEATH. THE CUSTOMER HAD BEEN HAVING SOME ISSUES WITH HER DIABETES PRIOR TO PASSING; ISSUES WITH LOW BLOOD GLUCOSE. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THE CALLER STATED THAT THE BATTERY IN THE INSULIN PUMP WAS DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572530 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death