BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1192453 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01532
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 18, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HE HAS HAD 4 INSULIN INFUSION SETS FROM THE SAME BOX LEAK AT THE HEADSET. HE STATED THIS FIRST BEGAN 3 WEEKS AGO, AND THE MOST RECENT INCIDENT OCCURRED TODAY. HE STATED EACH TIME HE NOTICED WETNESS AT THE SITE AND HIS BLOOD GLUCOSE WAS ELEVATED WITH TODAY'S READING BEING 290 MG/DL. HIS TARGET BLOOD GLUCOSE IS 90-100 MG/DL. HE STATED THAT HE "FELT LIKE I HAD HIGH BLOOD SUGAR" AND BOLUSED TO CORRECT HIS READINGS WHICH IS WHEN HE NOTICED THE HEADSET LEAKING. HE STATED THAT HE DID NOT KEEP ANY OF THE INFUSION SETS. ON FOLLOW UP WITH THE PT ON EIGHT DAYS LATER, HE STATED HIS BLOOD GLUCOSE HAS RETURNED TO THE NORMAL RANGE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED. ON PRODUCT WAS AVAILABLE 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 593513

    Patients

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