Description of Event or Problem · 1
THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR 82-84 PATIENT SAMPLES FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). REPEAT TESTING WAS PERFORMED WITH A NEW LOT OF CALCIUM REAGENT(LOT NUMBER NOT PROVIDED). REPEAT TESTING FOR PATIENTS 1 THROUGH 16 WAS PERFORMED ON (B)(6) 2010. OF THE DATA PROVIDED, THE RESULTS FOR 17 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 9.2 AND THE REPEAT RESULT WAS 11.1. PATIENT SAMPLE 2 FROM A MALE BORN ON (B)(6), THE INITIAL RESULT ON (B)(6) 2010 WAS 7.9 AND THE REPEAT RESULT WAS 10.7. PATIENT SAMPLE 3 FROM A MALE BORN ON (B)(6), THE INITIAL RESULT ON (B)(6) 2010 WAS 8.6 AND THE REPEAT RESULT WAS 10.6. PATIENT SAMPLE 4 FROM A MALE BORN ON (B)(6), THE INITIAL RESULT ON (B)(6) 2010 WAS 8.7 AND THE REPEAT RESULT WAS 10.7. PATIENT SAMPLE 5 FROM A MALE BORN ON (B)(6), THE INITIAL RESULT ON (B)(6) 2010 WAS 9.0 AND THE REPEAT RESULT WAS 11.0. PATIENT SAMPLE 6 FROM A MALE BORN ON (B)(6), THE INITIAL RESULT ON (B)(6) 2010 WAS 10.0 AND THE REPEAT RESULT WAS 12.0. PATIENT SAMPLE 7 FROM A FEMALE BORN ON (B)(6), THE INITIAL RESULT ON (B)(6) 2010 WAS 9.2 AND THE REPEAT RESULT WAS 10.6. PATIENT SAMPLE 8 FROM AN (B)(6) MALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 10.9 AND THE REPEAT RESULT WAS 8.9. PATIENT SAMPLE 9 FROM A (B)(6) FEMALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 12.3 AND THE REPEAT RESULT WAS 10.1. PATIENT SAMPLE 10 FROM A (B)(6) MALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 11.0 AND THE REPEAT RESULT WAS 9.1. PATIENT SAMPLE 11 FROM A (B)(6) FEMALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 10.9 AND THE REPEAT RESULT WAS 8.9. PATIENT SAMPLE 12 FROM A 79 YEAR OLD FEMALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 10.7 AND THE REPEAT RESULT WAS 8.9. PATIENT SAMPLE 13 FROM A (B)(6) MALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 10.7 AND THE REPEAT RESULT WAS 8.7. PATIENT SAMPLE 14 FROM A (B)(6) MALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 10.6 AND THE REPEAT RESULTS WERE 8.9 AND 8.6. PATIENT SAMPLE 15 FROM A (B)(6) FEMALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 10.6 AND THE REPEAT RESULT WAS 8.8. PATIENT SAMPLE 16 FROM A (B)(6) FEMALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 11.5 AND THE REPEAT RESULT WAS 8.9. PATIENT SAMPLE 17 FROM AN (B)(6) MALE, THE INITIAL RESULT ON (B)(6) 2010 WAS 11.7 AND THE REPEAT RESULT ON (B)(6) 2010 WAS 9.5. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE ISSUED. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE REAGENT CASSETTE AND THERE WAS IMPRECISE PIPETTING. HE REPLACED THE REAGENT CASSETTE, DEGASSER, FILTER, SAMPLE PROBES AND VALVES AND ALSO DECONTAMINATED THE SYSTEM. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTS AND QUALITY CONTROL. 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.