BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDER INFUSION SET

    MDR report key: 974362 · Received January 4, 2008

    Report

    Report Number
    2183996-2007-01937
    Event Type
    Injury
    Date Received
    January 4, 2008
    Date of Event
    December 31, 2007
    Report Date
    December 31, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S - AHOLMVEJ 1, OSTED.

    Description of Event or Problem · 1

    IN 2007, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT'S INFUSION TUBING SEPARATED AT THE LUER CONNECTION RESULTING IN ELEVATED BLOOD GLUCOSE. AT 7PM ON THE EVENT DATE, THE PATIENT'S BLOOD GLUCOSE MEASURED 302 MG/DL AND SHE HAD A HEADACHE. SHE THEN FOUND INSULIN LEAKING FROM THE INFUSION TUBING NEAR THE LUER CONNECTION. SHE STATED THAT HER CLOTHING WAS WET WITH INSULIN AND SHE COULD SMELL INSULIN. SHE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND BOLUSED 3.5 UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. THE MOTHER REPORTED THAT THE PATIENT SPENT THE NIGHT AT A FRIEND'S HOUSE AND SLEPT ON THE FLOOR WHICH MAY HAVE CAUSED STRAIN ON THE INFUSION TUBING. SHE STATED THAT WHEN THE PATIENT REMOVED THE INFUSION SITE THERE WAS BLOOD IN THE CANNULA. UPON FOLLOW UP THE FOLLOWING MONTH, THE PATIENT'S MOTHER STATED THAT THE PATIENT'S BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDER INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 589739

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention INSULIN INFUSION PUMP| INSULIN