BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE B-GLUCOSE MICROCUVETTES AND PHOTOMETE

    MDR report key: 763959 · Received September 22, 2006

    Report

    Report Number
    3003044483-2006-00001
    Event Type
    Injury
    Date Received
    September 22, 2006
    Date of Event
    August 12, 2006
    Report Date
    August 28, 2006
    Manufacturer
    HEMOCUE AB
    Product Code
    CGA
    PMA / PMN Number
    K911141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY; INVESTIGATION IF THE CUVETTES HAVE BEEN STORED IMPROPERLY. THIS COULD EFFECT THE MEASUREMENT WITH INCREASED MEASUREMENT VALUES. THE CUVETTES FROM THE SAME VIAL AS THOSE USED DURING THE INCIDENT WERE RETRIVED AT THE HOSPITAL VISIT. THEY SHOW NO EVIDENCE OF IMPROPER STORAGE INVESTIGATION OF THE INSTRUMENT INVOLVED IN THE INCIENT INCLUDING CALIBRATION CHECK, LED READING, VISUAL INSEPECTION, CONTROL CUVETTE DEVIATION, WAVELENGTH CONTROL, PRECISION AND ACCURACY, READ SWITCH CONTROL, VISUAL INSEPCTION OF PCB AND WIRING IS PERFORMED. NO MEASUREMENTS WERE OUT OF SPECIFICATION AND NO DETECTABLE SIGN OF POOR WIRING OR DAMAGES TO THE PCB ARE FOUND. IMPACTS FROMEXTERNAL EMC OR OTHER ELECTRICAL DISTURBANCE ON THE MEASUREMENT WERE PERFORMED ON THE SAME KIND OF INSTRUMENT INVOLVED IN THE INCIDENT. THE INVESTIGATION SHOWS THE INSTRUMENT IS INFLUENCED BY EMC AT CERTAIN FREQUENCIES THE INSTRUMENT WILL NOT GIVE FALSE VALUES BUT INSTEAD SHOW AN ERROR CODE. IF AN ERROR CODE IS SHOWN NO MEASUREMENT VALUE WILL BE DISPLAYED. THE INVESTIGATIONS ARE PERFORMED ON THE SAME KIND OF INSTRUMENT AND CUVETTES AS THOSE INVOLVED IN THE INCIDENT. INVESTIGATION OF IMPACT FROM BLOOD OUTSIDE THE CUVETTE ON THE MEASUREMENT. THIS INVESTIGATION SHOWS AND IMPACT ONT HE MEASURED VALVE WITH MAXIMUM 1 MMO1/L INVESTIGATION OF IMPACT ON THE MEASURED VALVE IF THE CURVETTES WERE NOT MEASURED WITHIN TIMEFRAME STATED IN PACKAGE INSERT. THE IMPACT ON THE MEASURED VALVE IS AN INCREASE OF THE VALVE BY APPROXIMATELY 0,5 MMO1/L IF THE CUVETTE IS MAEASURED AFTER 10 MINUTES INSTEAD OF AFTER 40 SECONDS AS STATED IN PACKAGE INSERT. CONTRIBUTION TO A B-GLUCOSE MEASUREMENT WITH EXTERNAL SUGAR SOURCES (CONTAMINATION) AN INVESTIGATION WITH CONTAMINATION SOURCES SUCH AS , D-GLUCOSE, DEXTROSE, GRANULATED SUGAR AND COCA COLA WERE PERFORMED D-GLUCOSE, DEXTROSE AND COCA-COLA RAISED THE MEASURED VALUE SO MUCH THAT THE INSTRUMENT SHOWED HHH. THIS MEANS THE VALVE EXCEEDED THE NSTRUMENTS UPPER MEASURING RANGE THAT IS 22,2 MMO1/L . INVESTIGATION IS RED BLOOD CELLS NOT HAEMOLYSED CAN GIVE FALSE HIGH READINGS, I.E MEASUREMENT OF THE CUVETTE BEFORE END REACTION. MEASUEMENT BEFORE END REACTION WILL RAISE THE MEASURED VALUE WITH A MAXIMUM OF 1 MM01/L INVESTIATION OF PATIENT PLASMA TO CONCLUDE IF THERE IS ANYTHING IN THE PLASMA AFFECTING THE MEASUREMENT. PLASMA WAS ANALYZED IN PARALLEL WITH A B GLUCOSE INSTRUMENT AND A BECKMAN INSTRUMENT ALL MEASUREMENT CORRELATED. INVESTIGATION OF OLD COMPLAINTS IF THERE ARE RELATED ISSUES TO BE OF HELP. AS OF TODAY, WE HAVE NO INFORMATION IN OLD COMPLAINTS ON VERSION UNDER INVESTIGATION THAT CAN HELP THIS CURRENT INVESTIGATION. COMPILATION OF BATCH HISTORY FOR INSTRUMENT AND CUVETTES. THE INSTURMENT CALIBRATION DOCUMENTATION FROM 2000 SHOWS AN INSTRUMENT WITH GOOD PRECISION AND ACCURACY. BATCH DOCUMENTATION FOR THE CUVETTE BATCH INVOLVED IN THE INCIDENT SHOWS ALL VALUES TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN 2006, THE HEMOCUE GLUCOSE ANALYZER WAS INVOLVED IN A SERIOUS INCIDENT. A MALE PATIENT WAS ADMITTED TO THE ICU CONCERNING A PERFORATED TUMOR WITH CONCOMITANT SEPSIS. DUE TO THE PATIENT'S SEVERE MEDICAL CONDITIONS, SEVERAL DRUGS WERE ADMINISTRED TO HIM. DUE TO SEVERE UNSTABLE DIABETES, THE PATIENT WAS REGULARLY CHECKED, ACCORDING TO STANDARD OPERATING PROCEDURE, BOTH AT THE ICU WITH HEMOCUE AS AT THE LABORATORY. ON THE SAME DAY, THE MEMOCUE INDICATED A GLUCOSE MEASUREMENT OF 13,5 MMO1/L WHILE THE TEST RESULT IN THE LABORATORY INDICATED A MEASUREMENT OF 1 MMO1/L. UPON REPEATED TESTING IN THE LABORATORY, AGAIN A MEASUREMENT OF 1 MMO1/L WAS FOUND. THE HYPOGLYCEMIC STATE OF THE PATIENT HAS LED TO VEGETATIVE STATE. THE HOSPITAL HAS BEEN UNABLE TO REPRODUCE THE EVENT HOWEVER A READING ERROR WAS CONSIDERED TO BE IMPOSSIBLE. HEMOCUE HAS PERFORMED VARIOUS EVALUATIONS TO SEARCH FOR THE ROOT CAUS. WE ARE NOT AWARE OR ANY EVIDENCE TO SUGGEST THE HEMOCUE E GLUCOSE ANAYLZING SYSTEM IS CAUSATIVE TO THIS ADVERSE EVENT, BUT CANNOT DECISIVELY CONCLUDE THAT THEY WERE NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE B-GLUCOSE MICROCUVETTES AND PHOTOMETE IVD CGA HEMOCUE AB NA 6051342

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization OF INCIDENT.| DOBUTAMIN/ADRENERGA AND DOPAMINERGA| NORADRENALIN| SUFENTANIL OPOIDANESTETIKA| GLUCOSE/DODIUM CHLORIDE INTRAVENOUS SOLUTION| AMIODARON/ANTIRYHMIC/IODINE| MIDASOLOM/ BENZODIAZIPINE| 14% OXYGEN FRACTIONAL| PATIENT IS ON VENTILATOR HAS NORMAL BLOOD GASES| DIGOXINE| CEFALEXIN ANTIBIOTICS| GENTAMYCIN ANTIBIOTICS| FOUR FACTOR ANTICOGULATION| METRANIDAZOL ANTIBIOTICS| MAGNESIUM SULPHATE| PROTROMBINECOMPLEX COFACT SANGUIN| INSULIN ACTRAPID| ONLY FACTOR II AND X WOULD STILL BE ACTIVE TIME| POTASSIUM CHLORIDE| NADROPARINE ANTICOAGULATION