BERICHROM ANTITHROMBIN III

Description of Event or Problem

FALSELY ELEVATED ANTITHROMBIN III RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES RUN ON THE BCS XP INSTRUMENT. A PATIENT RESULT WAS REPORTED TO THE PHYSICIAN FOR ONE OF THE SAMPLES. BOTH SAMPLES WERE REPEATED AFTER THE THROMBIN REAGENT USED WAS REPLENISHED. LOWER RESULTS WERE OBTAINED AND CORRECTED RESULT WERE REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED ANTITHROMBIN III RESULTS. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE FALSELY ELEVATED ANTITHROMBIN III RESULTS.

Additional Manufacturer Narrative

THE CAUSE OF THE FALSELY ELEVATED ANTITHROMBIN III (ATIII) RESULTS IS USER ERROR. SIEMENS CUSTOMER CARE CENTER REPRESENTATIVES INVESTIGATION OF INSTRUMENT DATA HAS DETERMINED THE SEQUENCE OF EVENTS LEADING TO THE DISCREPANT ELEVATED RESULTS. THE CUSTOMER INDICATED IN THE COMPLAINT THAT THEY HAD RUN OUT OF THE THROMBIN REAGENT USED IN THE ATIII TEST AFTER THE INITIAL PROCESSING OF THE SAMPLES. REVIEW OF THE INSTRUMENT FILES INDICATED INSUFFICIENT REAGENT ERRORS WERE PRESENT PRIOR TO SAMPLE PROCESSING. THERE IS NO INDICATION OF INSTRUMENT MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.