BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRDGM INSULIN PUMP

    MDR report key: 7987334 · Received October 19, 2018

    Report

    Report Number
    2032227-2018-46111
    Event Type
    Death
    Date Received
    October 19, 2018
    Date of Event
    May 2, 2017
    Report Date
    October 19, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS UNKNOWN. THE REPORTING PARTY DID NOT STATE WHETHER THE CUSTOMER HAD ANY ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS MOST LIKELY WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THERE IS PENDING LEGAL ACTION FOR THIS INCIDENT. THE REPORTING PARTY DID NOT STATE WHETHER THEY WOULD RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-UNK-RSVR UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828080 PRDGM INSULIN PUMP - PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death