BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCUE GLUCOSE 201DM SYSTEM

    MDR report key: 4109407 · Received September 12, 2014

    Report

    Report Number
    3003044483-2014-00011
    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
    PMA / PMN Number
    K041230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY CONCLUSION: AT THIS STAGE OF THE INVESTIGATION, BASED ON THE INFO KNOWN AND EVALUATIONS AND TESTS PERFORMED TO DATE, THE FILLING TECHNIQUE OF THE MICROCUVETTES USED BY THE CUSTOMER/HOSPITAL IN THE EVENT IS FOUND TO BE THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT OBTAINED WITH THE HEMOCUE GLUCOSE 201 DM SYSTEM. (PLEASE SEE THE EVALUATION SUMMARY AND HEMOCUE GLUCOSE 201 MICROCUVETTE PACKAGE INSERT) THE CONTRIBUTION OF THE DISCREPANT RESULT TO THE DEATH OF THE PT IS NOT KNOWN BY HEMOCUE AB TODAY. A DETAILED DESCRIPTION OF THE CHRONOLOGY OF EVENTS, REASON FOR CARDIAC ARREST AND SUBSEQUENT DEATH HAS NOT BEEN PROVIDED BY THE HOSP.

    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 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565076 HEMOCUE GLUCOSE 201DM SYSTEM GLUCOSE TEST SYSTEM LFR HEMOCUE AB 1405261

    Patients

    Seq Age Sex Outcome Treatment
    1 Death