Description of Event or Problem · 1
THE USER RECEIVED QUESTIONABLE RESULTS FOR CALCIUM ON THE INTEGRA 400 PLUS ANALYZER, SERIAL NUMBER (B)(4). THE EVENT INVOLVED 43 PATIENT SAMPLES. TWENTY FIVE PATIENT SAMPLES GAVE DISCREPANT RESULTS. PATIENT SAMPLE 1, THE INITIAL CALCIUM RESULT WAS 10.4 MG/DL, THE REPEAT RESULT WAS 9.1 MG/DL. PATIENT SAMPLE 2, THE INITIAL CALCIUM RESULT WAS 10.4 MG/DL, THE REPEAT RESULT GAVE 9.2 MG/DL. PATIENT SAMPLE 3, THE INITIAL CALCIUM RESULT WAS 9.7 MG/DL, THE REPEAT RESULT GAVE 8.4 MG/DL. PATIENT SAMPLE 4, THE INITIAL CALCIUM RESULT WAS 10.5 MG/DL, THE REPEAT RESULT GAVE 8.9 MG/DL. PATIENT SAMPLE 5, THE INITIAL CALCIUM RESULT WAS 9.1 MG/DL, THE REPEAT RESULT WAS 10.6 MG/DL. PATIENT SAMPLE 6, THE INITIAL CALCIUM RESULT WAS 10.4 MG/DL, THE REPEAT RESULT WAS 8.8 MG/DL. PATIENT SAMPLE 7, THE INITIAL CALCIUM RESULT WAS 10.4 MG/DL, THE REPEAT RESULT WAS 8.6 MG/DL. PATIENT SAMPLE 8, THE INITIAL CALCIUM RESULT WAS 10.2 MG/DL, THE REPEAT RESULT WAS 8.9 MG/DL. PATIENT SAMPLE 9, THE INITIAL CALCIUM RESULT WAS 9.6 MG/DL, THE REPEAT WAS 8.0 MG/DL. THIS REPEAT RESULT WAS ACCOMPANIED BY A DATA FLAG. PATIENT SAMPLE 10, THE INITIAL CALCIUM RESULT WAS 10.3 MG/DL, THE REPEAT RESULT WAS 8.3 MG/DL. THIS REPEAT RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2010 GIVING 9.1 MG/DL. PATIENT SAMPLE 11, THE INITIAL CALCIUM RESULT WAS 10.2 MG/DL, THE REPEAT RESULT WAS 8.0 MG/DL. THIS REPEAT RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2010 GIVING 9.1 MG/DL. PATIENT SAMPLE 12, THE INITIAL CALCIUM RESULT WAS 10.4 MG/DL, THE REPEAT RESULT WAS 8.1 MG/DL. THIS REPEAT RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2010 GIVING 9.4 MG/DL. PATIENT SAMPLE 13, THE INITIAL CALCIUM RESULT WAS 9.5 MG/DL, THE REPEAT RESULT WAS 7.3 MG/DL. THIS REPEAT RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2010 GIVING 8.4 MG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2010, PATIENT SAMPLES 14 THROUGH 20 WERE INITIALLY RUN AND REPEATED. THESE SAME PATIENT SAMPLES WERE REPEATED A SECOND TIME ON (B)(6) 2010 WITH A NEW CALCIUM REAGENT LOT NUMBER. PATIENT SAMPLE 14, THE INITIAL CALCIUM RESULT WAS 9.4 MG/DL, THE REPEATED RESULTS WERE 8.2 AND 9.0 MG/DL. THE FIRST REPEAT CALCIUM RESULT OF 8.2 MG/DL WAS ACCOMPANIED BY A DATA FLAG. PATIENT SAMPLE 15, THE INITIAL CALCIUM RESULT WAS 10.1 MG/DL, THE REPEATED RESULTS WERE 8.9 AND 9.6 MG/DL. PATIENT SAMPLE 16, THE INITIAL CALCIUM RESULT WAS 9.4 MG/DL, THE REPEATED RESULTS WERE 8.1 AND 9.0 MG/DL. THE FIRST REPEAT CALCIUM RESULT OF 8.1 MG/DL WAS ACCOMPANIED BY A DATA FLAG. PATIENT SAMPLE 17, THE INITIAL CALCIUM RESULT WAS 10.0 MG/DL, THE REPEATED RESULTS WERE 8.7 AND 9.8 MG/DL. PATIENT SAMPLE 18, THE INITIAL CALCIUM RESULT WAS 10.3 MG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE REPEATED RESULTS WERE 8.7 AND 10.1 MG/DL. PATIENT SAMPLE 19, THE INITIAL CALCIUM RESULT WAS 9.6 MG/DL, THE REPEATED RESULTS WERE 8.6 AND 9.7 MG/DL. PATIENT SAMPLE 20, THE INITIAL CALCIUM RESULT WAS 9.5 MG/DL, THE REPEATED RESULTS WERE 8.5 AND 9.6 MG/DL. PATIENT SAMPLE 21, THE INITIAL CALCIUM RESULT WAS 9.4 MG/DL, THE REPEATED RESULTS WERE 8.1 AND 9.5 MG/DL. THE FIRST REPEAT CALCIUM RESULT OF 8.1 MG/DL WAS ACCOMPANIED BY A DATA FLAG. PATIENT SAMPLE 22, THE INITIAL CALCIUM RESULT WAS 9.1 MG/DL, THE REPEATED RESULTS WERE 8.3 AND 9.7 MG/DL. THE FIRST REPEAT CALCIUM RESULT OF 8.3 WAS ACCOMPANIED BY A DATA FLAG. PATIENT SAMPLE 23, THE INITIAL CALCIUM RESULT WAS 9.7 MG/DL, THE REPEATED RESULTS WERE 8.8 AND 10.2 MG/DL. PATIENT SAMPLE 24, THE INITIAL CALCIUM RESULT WAS 9.1 MG/DL, THE REPEATED RESULTS WERE 8.6 AND 9.4 MG/DL. PATIENT SAMPLE 25, THE INITIAL CALCIUM RESULT WAS 8.7 MG/DL, THE REPEATED RESULTS WERE 9.1 AND 9.5 MG/DL. THERE WERE NO ERRONEOUS RESULTS REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT AFFECTED BY THIS EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE CALCIUM REAGENT. HE REPLACED THE CALCIUM REAGENT. PERFORMANCE TESTS WERE RUN AND PASSED. INTERNAL INVESTIGATIONS REVEALED THE PRESENCE OF PRECIPITATE IN REAGENT 2 (R2) OF THE CALCIUM REAGENT LOT. THE ROOT CAUSE FOR THE PRECIPITATION IS STILL UNDER INVESTIGATION. AN URGENT MEDICAL DEVICE REMOVAL NOTICE WAS MAILED (B)(6) 2010 TO ALL CUSTOMERS TO IMMEDIATELY DISCONTINUE USE OF THE CALCIUM REAGENT LOT. CALCIUM DEVIATIONS OF > 20% ABOVE AND BELOW THE REFERENCE RANGE ARE CONSIDERED CRITICAL. THESE DEVIATIONS COULD LEAD TO NON-DETECTION OF A PATHOLOGICAL STATUS OR MAY LEAD TO UNNECESSARY THERAPEUTIC CONSEQUENCES. THE ERRONEOUS BIAS CAUSED BY THIS ASSAY LOT MAY CAUSE PATIENT SAMPLES WITH CRITICALLY HIGH OR CRITICALLY LOW CALCIUM LEVELS TO HAVE RESULTS THAT APPEAR TO BE IN THE NORMAL RANGE. THESE PATIENTS MAY BE AT HIGH RISK FOR MISDIAGNOSIS OF PATHOLOGICAL CONDITIONS ASSOCIATED WITH ABNORMAL CALCIUM LEVELS. INACCURATELY HIGH CALCIUM VALUES MAY LEAD TO AN INCORRECT DIAGNOSIS DEPENDING ON THE BLOOD CALCIUM LEVEL. IN THE WORST CASE, THE WRONG THERAPY MAY BE INITIATED. SUSPECTED HYPERCALCEMIA WOULD MEAN CONFIRMING THE CALCIUM VALUE QUICKLY, AND TREATMENT WOULD OCCUR ACCORDING TO THE CLINICAL PICTURE. A PATIENT NORMALLY SHOWS OBVIOUS SYMPTOMS IF THE CALCIUM VALUE IS >12 MG/DL. IN THE CASE OF INACCURATELY LOW VALUES, THE CALCIUM VALUE MUST BE INTERPRETED TOGETHER WITH OTHER PARAMETERS (E.G., MAGNESIUM, PHOSPHATE, AND PTH). UNNECESSARY FURTHER EXAMINATION AND BLOOD COLLECTION MAY RESULT.