BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 4432057 · Received January 20, 2015

    Report

    Report Number
    1823260-2015-00419
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    December 18, 2014
    Report Date
    March 11, 2015
    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

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FROM 142 - 328 MG/DL; TOOK CORRECTION. PATIENT STATED AT THE LAST CORRECTION HE OBSERVED A WET SELF-ADHESIVE. PATIENT WAS ABLE TO GET HIS BLOOD GLUCOSE LEVEL UNDER CONTROL BY HIMSELF. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46265 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5026855

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR