BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1252786 · Received December 4, 2008

    Report

    Report Number
    2183996-2008-01825
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 13, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S HUSBAND REPORTED HE NOTICED A "HANDFUL OF BUBBLES IN THE LINE" OF THE PATIENT'S INSULIN INFUSION SET. HE STATED THERE ARE NO AIR BUBBLES IN THE INSULIN CARTRIDGE. THE PATIENT USES ROOM TEMPERATURE INSULIN TO FILL THE CARTRIDGE. HE SAID THE INFUSION HEADSET AND TUBING WERE CHANGED TODAY AT ABOUT 10AM AND AT 12PM THE PATIENT'S BLOOD GLUCOSE MEASURED 171 MG/DL. SHE BOLUSED 5 UNITS OF INSULIN AND AT 4PM HER READING WAS 266 MG/DL. TO TROUBLESHOOT AND WHILE THE TUBING WAS DISCONNECTED FROM THE HEADSET, THE HUSBAND WAS ASSISTED WITH PRIMING THE AIR BUBBLES OUT OF THE TUBING. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 605701

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention INSULIN| INSULIN INFUSION PUMP