BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC INFUSION SET QUICK-SET PARADIGM

    MDR report key: 7240420 · Received February 5, 2018

    Report

    Report Number
    3003442380-2018-00009
    Event Type
    Death
    Date Received
    February 5, 2018
    Date of Event
    September 17, 2017
    Report Date
    February 5, 2018
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006492
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TOGETHER WITH MEDTRONIC UNOMEDICAL IS STILL TRYING TO OBTAIN FURTHER INFORMATION AND, POSSIBLY, ALSO TO OBTAIN THE INFUSION SET USED AT TIME OF THE PRIMARY INCIDENT. IF NEW, RELEVANT INFORMATION BECOMES AVAILABLE, WE WILL REOPEN THE CASE AND ACT APPROPRIATELY, INCLUDING PROVIDING A FOLLOW-UP REPORT TO FDA. IT IS HOWEVER INCREASING LIKELY THAT WE WILL NOT BE ABLE TO MORE INFORMATION.

    Description of Event or Problem · 1

    (B)(4). NOTE: THIS CASE INVOLVES (B)(6) CITIZEN AND OCCURS IN THE (B)(6). A FEMALE DIABETIC PATIENT IS RECEIVING INSULIN VIA A MEDTRONIC INSULIN PUMP AND A MEDTRONIC QUICK-SET INFUSION SET. THE (B)(6) REPORTS SOME DETAILS FROM A 'USER REPORT' INCLUDING THAT ON (B)(6) 2017 A 'SUSPECTED FAULTY' INFUSION SET ALLEGEDLY MAY HAVE DELIVERED EXCESSIVE INSULIN RESULTING IN HYPOGLYCEMIA, BRAIN DAMAGE AND LASTLY, ON (B)(6) 2017, DEATH. EVEN AFTER INITIAL MEDTRONIC LOCAL INVESTIGATIONS IN (B)(6), THERE IS CONFUSION ON MANY DETAILS, INCLUDING PUMP (AND INFUSION SET) LOCATION(S). A (B)(6) CORONER REFER TO TWO DIFFERENT HOSPITALS - WHO BOTH REFER BACK TO THE CORONER. MEDTRONIC STAFF IS CONTINUING IN THEIR EFFORTS TO PROVIDE FURTHER INFORMATION. ANALYSIS OF THE PUMP'S INTERNAL MEMORY COULD PROVIDE IMPORTANT DATA. LIKEWISE, INVESTIGATION OF THE INFUSION SET USED AT TIME OF THE PRIMARY INCIDENT ON (B)(6) 2017 MAY PROVIDE IMPORTANT DATA. INFUSION SET LOT NUMBER: NOT KNOWN EXACTLY, BUT PROBABLY ONE OF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84812 MEDTRONIC INFUSION SET QUICK-SET PARADIGM INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-397 SEE NARRATIVE DESCR. 05705244006492

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L