BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 4781849 · Received May 19, 2015

    Report

    Report Number
    3011393376-2015-00453
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 20, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 THERE IS A LEAKAGE IN THE SYSTEM IN THE CONNECTION ZONE BETWEEN THE INSULIN CARTRIDGE AND THE INFUSION SET. PATIENT STATED SHE HAS BEEN PRESENTING WITH ALTERATIONS OF HER BLOOD GLUCOSE LEVELS SINCE A MONTH AGO. PATIENT REPORTED SHE DETECTED INSULIN IN THE CONNECTION ZONE BETWEEN THE INFUSION SET AND THE INSULIN CARTRIDGE WITH SEVERAL DIFFERENT LOTS OF THE INFUSION SET. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED CARTRIDGE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325212 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIABETES CARE, INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR HUMALOG INSULIN