BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 2073014 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01142
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 22, 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
    OK, 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) 2011, PATIENT REPORTED THAT THERE WAS INSULIN LEAKAGE FROM THE INFUSION SET. SHE NOTICED THE LEAK WHEN SHE SMELLED INSULIN AND WHEN THE INFUSION SET ADHESIVE BECAME WET. INFUSION SET IS CHANGED EVERY 3 DAYS. PATIENT DOES NOT KNOW HOW LONG THE INFUSION SET WAS IN USE BEFORE THE LEAK OCCURRED. HEADSETS ARE INSERTED MANUALLY AND AT AN ANGLE. THERE WAS NO POOLING OF INSULIN UNDER THE SKIN. PATIENT CHANGED THE HEADSET AND THE LEAK RESOLVED. FOLLOW-UP WAS COMPLETED WITH PATIENT ON (B)(6) 2011, AND PATIENT CONFIRMED THAT THE LEAK CAME FROM THE INFUSION SET CANNULA. ALLEGED INFUSION SET WAS DISCARDED AND NO PRODUCT WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN| INSULIN INFUSION DEVICE