BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4893586 · Received July 6, 2015

    Report

    Report Number
    2032227-2015-21350
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    March 1, 2014
    Report Date
    July 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.PLEASE SEE MEDWATCH REPORT 2032227-2014-01577.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER OF THE CUSTOMER CALLED TO REPORT THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CALLER WAS UNSURE OF THE EXACT DATE OF DEATH; THE CALLER STATED SOMETIME IN (B)(6) OF 2014. THE CAUSE OF DEATH WAS DKA. THE CALLER HUNG UP AFTER ADVISING THE CUSTOMER'S PASSING AND DID NOT PROVIDE ANY DETAILS. THE CALLER INSULIN PUMP; HENCE THE DEVICE INFORMATION COULD NOT BE VERIFIED. THE INSULIN PUMP INFORMATION WAS NOT CONFIRMED. THE INSULIN PUMP INFORMATION USED ON THIS MEDWATCH REPORT IS THE LAST KNOWN INSULIN PUMP TO HAVE BEEN ISSUED TO THE DECEDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435404 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death