BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5000565 · Received August 13, 2015

    Report

    Report Number
    2032227-2015-27344
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    July 31, 2015
    Report Date
    August 11, 2015
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP. NO DATA WAS LISTED FOR THE DATE OF 08/05/2015 DUE TO THE INSULIN PUMP BEING RECEIVED WITHOUT A BATTERY INSTALLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. ON THE NIGHT OF (B)(6) 2015, THE CUSTOMER WAS NOT FEELING GOOD; SHE HAD CHEST PAIN. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS HOSPITALIZED. THE CAUSE OF DEATH WAS MULTI ORGAN FAILURE DUE TO OTHER ISSUES THAT THE CUSTOMER HAD. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE LAST RECORDED BLOOD GLUCOSE VALUE WAS 108 MG/DL ON (B)(6) 2015 AT 2:46 AM. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT WAS REMOVED UPON ADMISSION TO THE HOSPITAL, BY THE EMERGENCY WORKERS. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534373 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization