BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION SET INSET

    MDR report key: 4286586 · Received November 21, 2014

    Report

    Report Number
    3003442380-2014-00097
    Event Type
    Death
    Date Received
    November 21, 2014
    Date of Event
    October 4, 2014
    Report Date
    November 19, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT TOOK PLACE IN (B)(6). A F/U OR FINAL REPORT WILL BE SUBMITTED NO LATER THAN (B)(4) 2014.

    Description of Event or Problem · 1

    EMAIL FROM PT'S HEALTHCARE PROFESSIONAL DATED (B)(6) 2014 AT 11:30 AM. IT IS WITH EXTREME SADNESS THAT I INFORM YOU ALL OF THE PASSING OF (REDACT) ON (B)(6). (REDACT) WAS DECLARED DECEASED AT 1729 IN THE (REDACT), IT HAS GONE TO THE CORONER. I SPOKE WITH (REDACT), (REDACT) MUM JUST NOW. (REDACT) HAS BEEN UNWELL LATELY, WAS FINDING IT DIFFICULT TO WALK, HAVING TO SIT DOWN FREQUENTLY DUE TO BEING OUT OF BREATH. ON SATURDAY AFTERNOON (REDACT)'S BG LEVELS WERE HIGH, SHE DID NOT CHECK HER KETONES. SHE COLLAPSED, WENT VERY PALE AND MADE GASPING NOISES, HER MOTHER CALLED THE AMBULANCE AT 1630, SHE WAS UNRESPONSIVE, ASYSTOLE ON FIRST RHYTHM CHECK BY AMBULANCE, CPR WAS COMMENCED AT THE SCENE, (REDACT) WAS INTUBATED. SHE PRESENTED TO ED IN ASYSTOLIC ARREST BUT WAS UNABLE TO BE REVIVED. ACCORDING TO (REDACT) THE CORONER DECLARED THE DEATH DUE TO DKA AND ATHEROSCLEROSIS CAUSING A HEART ATTACK. ON PRESENTATION TO ED PH 6.65, BG LEVEL 65.9, KETONES 6.7. DKA AND ATHEROSCLEROSIS CAUSING A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756784 INFUSION SET INSET INSET FPA UNOMEDICAL A/S 100-181-00 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death