BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC TENDER I

    MDR report key: 3111101 · Received May 3, 2013

    Report

    Report Number
    8021545-2013-00003
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    May 2, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED OR UNUSED DEVICES WERE RETURNED TO UNOMEDICAL FOR INVESTIGATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. NOTHING UNUSUAL WAS NOTED WITH THE INFUSION SITE ACCORDING TO THE REPORTER. THE CAUSE OF DEATH WAS REPORTED AS A RESULT OF AGGRESSIVE CANCER.

    Description of Event or Problem · 1

    ADDED (B)(6) 2013. PT EXPERIENCED A SERIOUS INJURY WHILE USING A ROCHE INFUSION SET. THE REPORT WAS REC'D ON (B)(6) 2012. HUSBAND REPORTED SHE WAS HOSPITALIZED FOR HYPERGLYCEMIA ON (B)(6) 2012. HUSBAND REPORTED THE INFUSION SET WAS NOT INSERTED CORRECTLY BY THE PT, AS SHE WAS UNABLE TO CORRECTLY OPERATE THE INFUSION DEVICE SYSTEM DUE TO LIMITED MEMORY AND AN AGGRESSIVE BRAIN TUMOR. THE PT HAD AN MRI ON (B)(6) 2012. SHE DISCONNECTED THE INFUSION DEVICE AND LEFT IT WITH HER HUSBAND, AND HE RECONNECTED THE INFUSION TUBE TO THE HEADSET FOLLOWING THE PROCEDURE. NOTHING UNUSUAL WAS NOTED WITH THE INFUSION SITE. HER BLOOD GLUCOSE INCREASED LATER THAT DAY, AND HUSBAND NOTICED BLOOD AT THE INFUSION SITE. PT REFUSED TO CHANGE THE SITE, AND HUSBAND TOOK HER TO THE EMERGENCY ROOM. PT WAS ADMITTED TO THE HOSPITAL, AND PHYSICIAN DECIDED TO DISCONTINUE USE OF THE INFUSION DEVICE. PT WAS TREATED WITH INSULIN INJECTION UNTIL SHE DIED ON (B)(6) 2012 DUE TO AGGRESSIVE CANCER. THE PT'S INFO WAS NOT PROVIDED; THEREFORE, NO FURTHER INFO COULD BE GATHERED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193489 AC TENDER I COMFORT INFUSION SET FPA UNOMEDICAL A/S 4541405001 646464

    Patients

    Seq Age Sex Outcome Treatment
    1 Death