BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3912382 · Received May 13, 2014

    Report

    Report Number
    3003044483-2014-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 13, 2014
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT FROM THE CUSTOMER WAS ON THE ANALYZER WHICH WAS RETURNED TO HEMOCUE (B)(4). THE ANALYZER WAS INVESTIGATED AND NO MALFUNCTION WAS FOUND. ON REQUEST FROM HEMOCUE (B)(4), THE CUSTOMER THEN RETURNED MICROCUVETTES FROM THE LOT NUMBER THEY HAD BEEN USING. THE INVESTIGATION OF 16 RETURNED SINGLE-PACKAGED MICROCUVETTES SHOWED THAT 3 PACKAGES WERE DAMAGED RELATED TO THE PRODUCTION PROCESS. CORRECTIVE AND PREVENTIVE ACTIONS ARE HANDLED IN THE HEMOCUE CAPA MANAGEMENT PROCESS.

    Description of Event or Problem · 1

    HEMOCUE RECEIVED A COMPLAINT ON HEMOCUE GLUCOSE 201+ ANALYZER FROM A (B)(6) CUSTOMER. THE HEMOCUE GLUCOSE 201+ ANALYZER WAS REPORTED GETTING DIFFERENT READINGS DURING PATIENT TESTING. THE REPORTED READINGS WERE 1, 9 MMOL/L AND 10,3 MMOL/L 2 MINUTES LATER. NO PATIENT IMPACT WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285567 HEMOCUE GLUCOSE 201 MICROCUVETTES GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110717 1402589

    Patients

    Seq Age Sex Outcome Treatment
    1