BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3943531 · Received July 18, 2014

    Report

    Report Number
    1823260-2014-05349
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 26, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED THE CONNECTOR WAS SEPARATED FROM THE INFUSION SET TUBE DURING USAGE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422284 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5033661

    Patients

    Seq Age Sex Outcome Treatment
    1