Description of Event or Problem · 1
THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON THEIR INTEGRA 400 ANALYZER FOR ONE PATIENT SAMPLE FOR ION SELECTIVE ELECTRODE (ISE) SODIUM, ISE POTASSIUM, ISE CHLORIDE, ALBUMIN GEN.2, CALCIUM, CREATININE PLUS VER.2, AND TOTAL PROTEIN GEN. 2. THE PATIENT'S INITIAL SODIUM RESULT WAS 114 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S INITIAL POTASSIUM RESULT WAS 3.1 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S INITIAL CHLORIDE RESULT WAS 85 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S INITIAL ALBUMIN RESULT WAS 2.5 G/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT'S INITIAL CALCIUM RESULT WAS 6.1 MG/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT'S INITIAL CREATININE RESULT WAS 0.69 MG/DL. THE PATIENT'S INITIAL TOTAL PROTEIN RESULT WAS 4.2 G/DL ACCOMPANIED BY A DATA FLAG. THE CUSTOMER PERFORMED THE INITIAL TESTING IN THE PRIMARY TUBE AND GOT WHAT SHE CONSIDERED ERRONEOUS RESULTS. SHE THEN POURED SERUM FROM THE PRIMARY TUBE INTO A SAMPLE CUP AND REPROCESSED. THE PATIENT'S SECOND SODIUM RESULT WAS 124 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S THIRD SODIUM RESULT WAS 122 MEQ/L ACCOMPANIED BY A DATA FAG. THE PATIENT'S SECOND POTASSIUM RESULT WAS 3.3 MEQ/L. THE PATIENT'S THIRD POTASSIUM RESULT WAS 3.3 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S SECOND CHLORIDE RESULT WAS 93 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S THIRD CHLORIDE RESULT WAS 92 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S SECOND ALBUMIN RESULT WAS 3.3 G/DL. THE PATIENT'S SECOND CALCIUM RESULT WAS 7.1 MG/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT'S THIRD CALCIUM RESULT WAS 7.2 MG/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT'S FOURTH CALCIUM RESULT WAS 7.3 MG/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT'S SECOND CREATININE RESULT WAS 0.81 MG/DL. THE PATIENT'S SECOND TOTAL PROTEIN RESULT WAS 5.5 G/DL ACCOMPANIED BY A DATA FLAG. THESE REPEAT RESULTS WERE REPORTED TO THE CUSTOMER'S SISTER LABORATORY SITE WHO REPORTED THEM TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE SODIUM RESULTS AS THE SISTER FACILITY HAD PREVIOUSLY RELEASED A SODIUM RESULT OF 139 FROM AN I-STAT ANALYZER. THE CUSTOMER REPEATED THE SAMPLE AGAIN USING ALIQUOT CUPS. THE PATIENT'S FOURTH SODIUM RESULT WAS 144 MEQ/L. THE PATIENT'S FIFTH, SIXTH, AND SEVENTH SODIUM RESULTS WERE 143 MEQ/L. THE PATIENT'S FOURTH POTASSIUM RESULT WAS 4.0 MEQ/L. THE PATIENT'S FOURTH CHLORIDE RESULT WAS 107 MEQ/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S THIRD ALBUMIN RESULT WAS 4.0 G/DL. THE PATIENT'S FIFTH CALCIUM RESULT WAS 8.7 MG/DL. THE PATIENT'S THIRD CREATININE RESULT WAS 0.93 MG/DL. THE PATIENT'S THIRD TOTAL PROTEIN RESULT WAS 6.6 G/DL. THE PATIENT WAS IN THE EMERGENCY ROOM AT THE TIME OF THE EVENT AND LATER ADMITTED TO THE HOSPITAL, BUT THE ADMISSION WAS NOT DUE TO THE ERRONEOUS RESULTS. THE CUSTOMER SPOKE TO THE PHYSICIAN AND NO TREATMENT WAS ADMINISTERED OR DELAYED DUE TO THE ERRONEOUS RESULTS. THERE WERE NO ADVERSE EVENTS. THE ALBUMIN REAGENT LOT NUMBER WAS 63988001 AND THE EXPIRATION DATE WAS 05/31/2012. THE CALCIUM REAGENT LOT NUMBER WAS 64833301 AND THE EXPIRATION DATE WAS 01/31/2012. THE CHLORIDE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CREATININE REAGENT LOT NUMBER WAS 64712801 AND THE EXPIRATION DATE WAS 04/30/2012. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 64301001 AND THE EXPIRATION DATE WAS 07/31/2012. THE PROBLEM WAS IDENTIFIED AS FIBRIN IN THE SAMPLE, AS CONFIRMED BY TWO DIFFERENT OPERATORS. THE CUSTOMER REPLACED PROBE C AND BELIEVES THIS RESOLVED THE ISSUE.