BEUDAMED
    FDA Adverse Event Other Summary report: N

    B-GLUCOSE DATA MANAGEMENT ANALYZER

    MDR report key: 813424 · Received January 19, 2007

    Report

    Report Number
    3003044483-2007-00001
    Event Type
    Other
    Date Received
    January 19, 2007
    Date of Event
    October 5, 2004
    Report Date
    December 20, 2006
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    k961311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT THAT COULD CAUSE SERIOUS INCIDENTS TOGETHER WITH USER MISTAKES.

    Description of Event or Problem · 1

    HEMOCUE AB HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS FROM 2004-2006. DURING THIS REVIEW, HEMOCUE AB FOUND ONE INCIDENT THAT SHOULD HAVE BEEN REPORTED AS AN MDR. A HEMOCUE GLUCOSE 95 DM INSTRUMENT WAS SENT IN FOR REPAIR TO HEMOCUE INC. WHEN THE CUSTOMER RETRIEVED THE REPAIRED INSTRUMENT, IT HAD A HEMOCUE HEMOGLOBIN 95 DM COVER INSTEAD OF THE GLUCOSE 95 DM COVER. THE INSTRUMENT WAS SENT BACK TO HEMOCUE INC AND THE COVER REPLACED TO THE CORRECT ONE. THIS EVENT COULD HAVE CONSEQUENCES FOR PT, BUT ONLY TOGETHER WITH USER MISTAKES. RISK SCENARIOS; THE CUSTOMER DOES NOT OBSERVE THE COVER STATES IT IS A HEMOCUE HEMOGLOBIN 95 DM INSTRUMENT AND USES IT AS USUAL FOR BLOOD GLUCOSE MEASUREMENTS. THE DISPLAY STILL STATES IT IS A B-GLUCOSE WHEN THE INSTRUMENT IS STARTED. B-GLUCOSE MICROCUVETTES ARE USED FOR THE MEASUREMENT. THE CORRECT MEASUREMENT WILL BE RETRIEVED AND THERE IS NO RISK FOR THE PT. THE CUSTOMER BELIEVES THE INSTRUMENT IS A HEMOCUE HEMOGLOBIN 95 DM EVEN THOUGH THE DISPLAY STILL STATES IT IS A B-GLUCOSE WHEN IT IS STARTED, AND TRIES TO MAKE MEASUREMENTS WITH THE HEMOCUE B-HB MICROCUVETTES. THE MICROCUVETTE WILL NOT FIT IN THE INSTRUMENT AND NO MEASUREMENT CAN BE DONE. NO RISK FOR A FALSE HB PT RESULT. THE CUSTOMER BELIEVES THE INSTRUMENT IS A HEMOCUE HEMOGLOBIN 95 DM, EVEN THOUGH THE DISPLAY STILL STATES IT IS A B-GLUCOSE WHEN IT IS STARTED, BUT USES A B-GLUCOSE MICROCUVETTE (WHICH WILL FIT IN THE INSTRUMENT) FOR THE MEASUREMENT. THE RESULT IS THEN INTERPRET AS AN HB RESULT, BUT IS A BLOOD GLUCOSE RESULT. HB IS NORMALLY MEASURED IN G/L AND BLOOD GLUCOSE IN MG/DL. IF THE PT HAS LOW BLOOD GLUCOSE, AROUND 60 MG/DL AND THIS RESULT IS MISTAKEN FOR 60 G/L HB, THE PT WOULD PROBABLY BE TREATED WITH A BLOOD TRANSFUSION. BLOOD TRANSFUSION IS A POSSIBLE PT RISK. NO INDICATION OF DEATH, OR SERIOUS INJURY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-GLUCOSE DATA MANAGEMENT ANALYZER LFR LFR HEMOCUE AB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other