BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6174226 · Received December 14, 2016

    Report

    Report Number
    2032227-2016-49930
    Event Type
    Death
    Date Received
    December 14, 2016
    Date of Event
    July 17, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT A HOSPITAL. THE CAUSE OF DEATH WAS SEVERE DIABETIC HYPOGLYCEMIA. WHEN THE SPOUSE RETURNED FROM WORK, AFTER 6PM, HE DISCOVERED THE CUSTOMER ON THE FLOOR. HE CHECKED THE CUSTOMER'S BLOOD GLUCOSE AND IT WAS AT 0.6 MMOL/L SO HE CALLED THE PARAMEDICS. THE SPOUSE STATED THAT HE ASSUMES THE CUSTOMER MUST HAVE DELIVERED A BOLUS WITHOUT HAVING A MEAL. THE CALLER DECLINED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824717 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death