THE CUSTOMER HAS OBTAINED OUT OF RANGE VALUES FOR QUALITY CONTROL (QC) SAMPLES ON THE DEHYDROEPIANDROSTERONE SULFATE (DHEA-SO4) ASSAY ON AN IMMULITE 2000 INSTRUMENT. PATIENT SAMPLE VALUES WERE REPORTED TO PHYSICIAN(S) DESPITE QC LEVELS 1 AND 2 BEING OUT OF RANGE HIGH, AND QC LEVEL 3 BEING OUT OF RANGE LOW. DISCORDANT (DHEA-SO4) RESULTS WERE OBTAINED FOR FOUR PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON SAME INSTRUMENT FOR ALL FOUR PATIENTS AND CORRECTED RESULTS WERE OBTAINED. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DHEA SO4 RESULTS.
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Patient 1
THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT QUALITY CONTROL (QC) WAS OUT OF RANGE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTALLED PREVENTIVE MAINTENANCE KIT. THE CSE ALSO RAN DECONTAMINATION ON THE WATER PUMP, WASH PROBE TUBING AND SUBSTRATE TOWER AND HEATER. CSE RAN WATER TEST AND QC. THE CAUSE OF DISCORDANT DHEA SO4 RESULTS IS UNKNOWN. THE CAUSE OF DISCORDANT PATIENT RESULTS BEING REPORTED TO PHYSICIAN(S) WHILE QC WAS OUT OF RANGE IS A FAILURE TO FOLLOW INSTRUCTIONS. AS PER THE IMMULITE 2000 DHEA SO4 INSTRUCTIONS FOR USE "USE CONTROLS OR SERUM POOLS WITH AT LEAST TWO LEVELS (LOW AND HIGH) OF DHEA-SO4". THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.