BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1250021 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01738
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2008 THE PATIENT REPORTED THAT "EARLIER IN THE YEAR" SHE WAS EXPERIENCING KINKED CANNULAS WITH HER INSULIN INFUSION SETS. SHE STATED THIS OCCURRED PRIOR TO MARCH 2008 AND SHE DOES NOT RECALL ANY SPECIFIC INFORMATION CONCERNING THE INCIDENTS. SITE SELECTION AND MANAGEMENT WERE DISCUSSED WITH THE PATIENT AND SHE WAS ADVISED TO SPEAK WITH HER DOCTOR ABOUT SITE LOCATIONS AND ABSORPTION DIFFERENCES. A COURTESY GUIDE TO INFUSION SITE MANAGEMENT WAS SENT TO THE PATIENT. NO BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR INSULIN INFUSION PUMP| INSULIN