BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRDGM INSULIN PUMP

    MDR report key: 7995627 · Received October 23, 2018

    Report

    Report Number
    2032227-2018-48089
    Event Type
    Death
    Date Received
    October 23, 2018
    Date of Event
    September 13, 2018
    Report Date
    October 23, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 BUT CONNECTED TO LOW BLOOD GLUCOSE. THE REPORTING PARTY DID NOT STATE IF 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 THE INCIDENT. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. NO FURTHER INFORMATION WAS PROVIDED AS THERE IS PENDING LEGAL ACTION. IT IS UNKNOWN IF THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR . UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837412 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 Death