BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 3842755 · Received June 2, 2014

    Report

    Report Number
    1823260-2014-03914
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 3 CARTRIDGES HAVE LEAKED INSULIN INTO THE INFUSION DEVICE. THERE ARE A FEW DROPS OF INSULIN INSIDE THE CARTRIDGE COMPARTMENT, BUT SHE WAS ABLE TO CLEAN MOST WITH A TISSUE. CUSTOMER WAS ADVISED HOW TO PROPERLY INSERT THE CARTRIDGE BY ATTACHING THE ADAPTER AND INFUSION TUBE FIRST. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320868 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 32075292

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR