BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISETRONIC TENDER

    MDR report key: 5508067 · Received January 6, 2005

    Report

    Report Number
    8021545-2005-00001
    Event Type
    Death
    Date Received
    January 6, 2005
    Report Date
    January 5, 2005
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ADHESIVE TAPE WAS VERY DIRTY/DISCOLOURED (DARK GREY), PROBABLY CAUSED BY THE PTS CONDITION. THE SAMPLE EXHIBITED A STREAM OF AIR BUBBLES INDICATING THAT THE SET PASSED THE TEST FOR FLOW AND THEREFORE WAS IN COMPLIANCE WITH THE SPECIFICATIONS. NO AIR BUBBLES APPEARED DURING THE TEST INDICATING THAT THE SET PASSED THE TEST FOR LEAKAGE AND THEREFORE WAS IN COMPLIANCE WITH THE SPECIFICATIONS. FROM THE INFO RECEIVED, THERE ARE NO INDICATIONS THAT THE INCIDENT IS RELATED TO DIABETES THERAPY. THE TESTS AND ANALYSIS MADE ON THE SET INVOLVED HAVE CONFIRMED COMPLIANCE WITH THE SPECIFICATION AND REQUIREMENT. BASED ON THE ABOVE FINDINGS IT CAN BE REASONABLY CONCLUDED THAT THE INFUSION SET HAD NEITHER CAUSED NOR CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2004 UNOMEDICAL A/S WAS INFORMED BY DISETRONIC MEDICAL SYSTEMS THAT A PT WAS FOUND DEAD IN "A STATE OF DECOMPOSITION" ON (B)(6) 2004 AT 11:30 AM. ACTUAL DATE OF DEATH HAS NOT BEEN DETERMINED. CAUSE OF DEATH HAS NOT BEEN DETERMINED. UNOMEDICAL HAS RECEIVED THE COMPLAINT AND 1 USED INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC TENDER SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S PT 17/60 (10+10) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death