BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 3791845 · Received May 6, 2014

    Report

    Report Number
    1823260-2014-03205
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE PISTON SEAL OF THE CARTRIDGE IS TOO SMALL, AND THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE BECAME WET WITH INSULIN. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272184 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 32464220

    Patients

    Seq Age Sex Outcome Treatment
    1