BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1241787 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01758
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 31, 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
    CA, 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 REPORTED HE HAS BEEN EXPERIENCING BENT CANNULAS WITH HIS INSULIN INFUSION SETS "FOR YEARS." HE SAID HE HAD A BENT CANNULA ABOUT A WEEK AGO AND HIS BLOOD GLUCOSE ELEVATED TO 354 MG/DL WITH HIS TARGET RANGE BEING 100-150 MG/DL. HE STATED HE CORRECT HIS READING BY CHANGING HIS HEADSET AND BOLUSING INSULIN. THE PT SAID HE CHANGES HIS HEADSET EVERY 2-4 DAYS AND WAS ADVISED THE RECOMMENDED USE IS NO LONGER THAN 3 DAYS. HE STATED HE BELIEVES THAT, DUE TO BEING ON AN INFUSION DEVICE FOR YEARS, HE HAS DEVELOPED SCAR TISSUE IN HIS ABDOMEN. SITE LOCATION AND ROTATION WERE DISCUSSED WITH THE PATIENT. HE STATED HE DOES NOT THINK ANOTHER LOCATION WILL WORK FOR HIM BECAUSE OF THE TYPE OF WORK HE DOES AND THE TOOL BELT HE WEARS. COMPLIMENTARY INFUSION SETS WERE SENT TO THE PATIENT ALONG WITH A GUIDE TO INFUSION SITE MANAGEMENT. 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 579986

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention INSULIN INFUSION PUMP| INSULIN