BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1063328 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00888
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 12, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT WHILE INSERTING AN INFUSION SITE, THE INTRODUCER NEEDLE OF THE HEADSET BENT. SHE STATED THAT SHE STRAIGHTENED THE INTRODUCER NEEDLE AND INSERTED THE INFUSION SITE. THE PT WAS ADVISED TO INSERT A NEW INFUSION SITE. SHE STATED THAT THIS HAS HAPPENED TWICE IN THE PAST TWO WEEKS. THE PT ALSO REPORTED THAT HER BLOOD GLUCOSE HAD CHANGED FROM 30-179 MG/DL. WHILE EXPERIENCING LOW BLOOD GLUCOSE, SHE DISCONNECTED FROM HER INFUSION DEVICE AND TOOK A GLUCOSE TAB. WHEN HER BLOOD GLUCOSE ELEVATED TO 179 MG/DL SHE RECONNECTED TO HER INFUSION DEVICE AND BEGAN DRINKING WATER. HER BLOOD GLUCOSE THEN RETURNED TO NORMAL (124 MG/DL). THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA 588705

    Patients

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