BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 2231664 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02085
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HIS INFUSION SITE WAS LEAKING. PT STATED, HE NOTICED A WET SPOT ON HIS SHIRT WHEN HE WAS GETTING READY TO EAT. PT REPORTED HE CHANGED THE INFUSION SITE 3 DAYS AGO. ADVISED PT ON PROPER SITE ROTATION. ADVISED PT THE INFUSION SITE NEEDS TO BE CHANGED. PT DIDN'T MENTION ANY DAMAGE TO THE INFUSION SET. PT STATED, HE WOULD CHANGE THE INFUSION SITE ON HIS OWN. ON F/U CALL ON (B)(6) 2011, PT REPORTED HE THINKS THE LEAK WAS COMING FROM THE INFUSION SET AND NOT FROM HIS BODY WHERE HIS INFUSION SITE WAS INSERTED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRED ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 6442226

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INSULIN| INSULIN INFUSION SET