BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 SYSTEM

    MDR report key: 8548764 · Received April 25, 2019

    Report

    Report Number
    3003044483-2019-00008
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    March 27, 2019
    Report Date
    June 10, 2019
    Manufacturer
    HEMOCUE AB
    Product Code
    CGA
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THE RETAINED CUVETTE LOTS MEASURED SLIGHTLY TOO LOW AT GLUCOSE LEVEL OF 43 MG/DL (WHOLE BLOOD) AND THUS THE CUSTOMER PROBLEM COULD NOT BE CONFIRMED. NO CAUSE WAS FOUND TO THE CUSTOMER PROBLEM.

    Additional Manufacturer Narrative · 1

    ADDED INFORMATION CATALOG AND LOT NUMBERS FOR MICROCUVETTES. ONLY ONE EXPIRATION DATE WAS POSSIBLE TO ENTER, SEE BELOW FOR MORE INFORMATION: LOT NUMBER 1810428 - EXPIRATION DATE 07/18/2019, LOT NUMBER 1808252 - EXPIRATION DATE 05/15/2019, LOT NUMBER 1801668 - EXPIRATION DATE 10/18/2018.

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS RETURNED TO HEMOCUE AB FOR INVESTIGATION. THE INVESTIGATION CONCLUDED THAT THE ANALYZER PERFORMED ACCORDING TO SPECIFICATION, THE CUSTOMER PROBLEM COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    HEMOCUE RECEIVED A COMPLAINT THAT THE ANALYZER ARE GIVING FALSE HIGH RESULTS. RESULTS FROM ONE PATIENT WAS RECEIVED, THE HEMOCUE GLUCOSE 201 SHOWED 70 MG/DL, THE PATIENT WERE SENT TO THE HOSPITAL WHERE THE LAB TEST SHOWED 35 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344696 HEMOCUE GLUCOSE 201 SYSTEM GLUCOSE TEST SYSTEM CGA HEMOCUE AB 120706 1810428, 1808252, 1801668

    Patients

    Seq Age Sex Outcome Treatment
    1