DIMENSION VISTA®

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE CUSTOMER CARE CENTER CONCERNING DISCORDANT ELEVATED ESTRADIOL RESULT. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) EVALUATED THE INFORMATION PROVIDED AND CONCLUDED THEIR INVESTIGATION OF THE EVENT. NO INSTRUMENT, QC, OTHER PATIENT RESULT, OR ASSAY RELATED ISSUES WERE REPORTED. NO E2 ASSAY OR VISTA SYSTEM ISSUES HAVE BEEN IDENTIFIED. THE CAUSE OF THE DISCORDANT ELEVATED ESTRADIOL RESULT IS UNKNOWN. RESULTS WERE QUESTIONED BY THE PROVIDER AS HIGHER RESULTS THAN WERE EXPECTED. IT IS UNCLEAR WHEN THE SAMPLE WAS DRAWN IN RELATIONSHIP TO THE REMOVAL OF THE OVARIES. HERE THE ESTRADIOL RESULT WAS BELIEVED TO BE ERRONEOUSLY ELEVATED COMPARED TO TWO OTHER METHODS. THE PATIENT WAS ON ORAL CONTRACEPTIVE MEDICATION, LOETTE, WHICH CONTAINS ESTRADIOL. THE IFU INDICATES UNDER THE LIMITATIONS OF PROCEDURE SECTION: "WITH THE ADVENT OF STEROID BASED MEDICATIONS (ANALOGUES) WITH SIMILAR CHEMICAL STRUCTURES TO ESTRADIOL, THERE IS THE POSSIBILITY OF CROSS-REACTIVITY AND RESULTS INCONSISTENT WITH THE PATIENTS CLINICAL HISTORY". THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

A DISCORDANT ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A PATIENT'S SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE SAME SAMPLE WAS TESTED BY TWO ALTERNATE NON-SIEMENS METHODOLOGIES AND LOWER RESULTS WERE OBTAINED CONSISTENT WITH PHYSICIAN EXPECTATIONS. THERE ARE NO REPORTS OF TREATMENT CHANGE OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED E2 RESULT.