BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1369898 · Received April 27, 2009

    Report

    Report Number
    2183996-2009-00575
    Event Type
    Injury
    Date Received
    April 27, 2009
    Date of Event
    April 6, 2009
    Report Date
    April 6, 2009
    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

    ON THE EVENT DATE, THE PT REPORTED THAT HER INFUSION TUBING BECAME DISCONNECTED FROM THE INFUSION DEVICE AT THE LUER CONNECTION. SHE BEGAN TO FEEL NAUSEATED AND THIRSTY AND HER BLOOD GLUCOSE WAS ELEVATED TO 490 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 70-220 MG/DL. SHE RECONNECTED THE INFUSION TUBING TO THE INFUSION DEVICE AND BOLUSED 9.5 UNITS OF INSULIN. SHE STATED THAT THE LUER LOCK OF THE INFUSION TUBING DID NOT APPEAR TO BE DAMAGED. SHE STATED THAT SHE SUFFERS FROM ARTHRITIS AND SHE WAS ADVISED TO CHECK THE INFUSION TUBING THROUGHOUT THE DAY. SHE STATED THAT THE ADAPTER HAD NEVER BEEN CHANGED AND SHE WAS ADVISED TO CHANGE THE ADAPTER WITH EVERY 10TH INSULIN CARTRIDGE CHANGE. 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 600395

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INSULIN| INSULIN INFUSION PUMP