BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCUE GLUCOSE 201DM SYS

    MDR report key: 4115280 · Received September 12, 2014

    Report

    Report Number
    1523456-2014-00005
    Event Type
    Death
    Date Received
    September 12, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO SIMULATE THE FILLING TECHNIQUE OF MICROCUVETTES USED DURING THE ADVERSE EVENT IN ORDER TO EVALUATE THE POSSIBLE IMPACT ON THE RESULT GIVEN BY THE HEMOCUE SYSTEM. FORCING BLOOD INTO THE CUVETTE THROUGH A SYRINGE (RATHER THAN THROUGH THE PROPER FILLING TECHNIQUE OF CAPILLARY ACTION) IS DIFFICULT AND BECOMES VERY MESSY. WITH THE IMPROPER FILLING TECHNIQUE, IT IS DIFFICULT TO ENSURE A COMPLETELY FILLED MICROCUVETTE AND TO ENSURE THAT NO BLOOD IS LEFT ON THE OUTSIDE OF THE MICROCUVETTE BEFORE PLACED FOR MEASUREMENT IN THE ANALYZER. UPON SIMULATING THE IMPROPER FILLING TECHNIQUE USED BY THE CUSTOMER/HOSPITAL, HEMOCUE HAS REPRODUCED THE DIFFERENCE IN RESULTS RECEIVED IN THE ADVERSE EVENT. A MICROCUVETTE, ANALYZED WITH SPECIMEN WITH A KNOWN BLOOD GLUCOSE LEVEL OF APPROX 50 MG/DL, WHICH UPON MEASUREMENT STILL HAS BLOOD LEFT ON THE OUTSIDE OF THE CUVETTE, I.E. HAS BEEN POORLY WIPED OFF GIVES DISCREPANT RESULTS. THE USED FILLING TECHNIQUE AND HANDLING MAY LEAD TO BOTH TOO HIGH AND TOO LOW RESULTS AS WELL AS DIFFERENT ERROR MESSAGES, LIKE ECU (EMPTY CUVETTE MESSAGE) WHICH THE CUSTOMER OBTAINED BEFORE. RESULTS IN THE RANGE AS OBTAINED BY THE CUSTOMER HAVE BEEN REPRODUCED WHEN THE CUSTOMER'S FILLING TECHNIQUE IS REPLICATED (BUT NOT WHEN THE PROPER FILLING TECHNIQUE PER THE INSTRUCTIONS FOR USE IS USED).

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER/HOSPITAL: A DIALYSIS PT, SCHEDULED FOR ROUTINE DIALYSIS, ENTERED A "CODE BLUE", IN CARDIAC ARREST. WHEN THE PT WAS IN CARDIAC ARREST, A BLOOD SAMPLE WAS TAKEN AND ANALYZED ON THE HEMOCUE GLUCOSE 201 DM SYSTEM. FIRST MEASUREMENT GAVE AN ERROR MESSAGE "EMPTY CUVETTE" AND SECOND MEASUREMENT GAVE 130 MG/DL. BASED ON THE HEMOCUE RESULT NO TREATMENT WITH DEXTROSE WAS INITIATED. THE PT EXPIRED. AFTER THE PT EXPIRED THE BLOOD GLUCOSE LEVEL WAS VERIFIED AT THE HOSPITAL LABORATORY USING A DIFFERENT SYSTEM. RESULTS OF 40 MG/DL AND 39 MG/DL WERE RECEIVED. THE SAMPLES WERE FROM THE SAME SYRINGE AS THE ONE ANALYZED ON THE HEMOCUE SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565214 HEMOCUE GLUCOSE 201DM SYS GLUCOSE TEST SYS LFR HEMOCUE AB 1405261

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death