BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT INSULIN CARTRIDGE

    MDR report key: 4192471 · Received October 22, 2014

    Report

    Report Number
    1823260-2014-08143
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    June 1, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6). 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

    IT WAS REPORTED THAT THE INSULIN CARTRIDGE HAD LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL OF 500 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE INSULIN CARTRIDGE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672096 ACCU-CHEK ® INSIGHT INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1