SYVA® EMIT ® 2000 TACROLIMUS

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2517506-2024-00243 ON 02-OCT-2024. ADDITIONAL INFORMATION ON 18-OCT-2024 SIEMENS INVESTIGATION DID NOT REPLICATE THE ISSUE REPORTED BY THE CUSTOMER. SIEMENS CONTINUES TO INVESTIGATE. NOTE: A SEPARATE SUPPLEMENTAL REPORT WILL BE FILED FOR THE SYVA® EMIT® 2000 TACROLIMUS LOT S4.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2517506-2024-00243 ON 02-OCT-2024. SIEMENS FILED SUPPLEMENTAL MDR 2517506-2024-00243-S1 ON 11-NOV-2024. ADDITIONAL INFORMATION 15-APR-2025: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: THE ALLEGATION OF REAGENT DEGRADATION CAUSING IMPRECISION AND INCREASED CALIBRATION WITH THE EMIT 2000 TACROLIMUS REAGENT LOTS S3 AND S4 WAS REVIEWED BY SIEMENS AND THE BEHAVIOR WAS NOT REPRODUCED WITH THE INTERNAL TESTING PERFORMED. THE REAGENT LOTS CONTINUED TO MEET THE ASSAY SPECIFICATIONS WHEN TESTED AT THE REAGENT PRODUCTION SITE. THE BEHAVIOR APPEARS TO BE SPECIFIC TO CERTAIN CUSTOMERS BUT THE AVAILABLE DATA LIMITED THE INVESTIGATION INTO THE PERFORMANCE OF THE ASSAY. CONCERN THAT THE QC AND CALIBRATION BEHAVIOR BEING REPORTED WERE DUE TO THE SIGNAL SEPARATION OF THE CALIBRATION POINTS BEING LOW COMPARED TO PREVIOUS REAGENT LOTS WAS ADDRESSED BY SIEMENS. AT NO TIME WERE THE SEPARATIONS OF THE SIGNAL IN THE REAGENT LOTS REPORTED OUTSIDE OF THE SEPARATION LIMITS. THE ALLEGATIONS OF QC IMPRECISION, REAGENT DEGRADATION AND CALIBRATION ISSUES APPEAR TO HAVE MULTIPLE CAUSES, HOWEVER THE CUSTOMER HAS DECLINED TO PROVIDE THE INSTRUMENT FILES NEEDED TO FULLY IDENTIFY THE ISSUES. THE DATA SUGGEST THAT THE INSTRUMENT MAY RECOVER A LOWER SIGNAL THAN OTHER ANALYZERS, OR THERE MAY BE SOME ISSUES WITH THE QC PRODUCTS AND POTENTIAL REAGENT HANDLING ISSUES DURING SHIPPING. DUE TO THE LIMITED DATA AND BEHAVIOR WAS NOT REPRODUCED BY SIEMENS, THE CAUSE OF THE ISSUE IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED AND NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS REMOTE SUPPORT CENTER (RSC) TO REPORT NON-REPRODUCIBLE RESULTS WHEN USING SYVA® EMIT® 2000 TACROLIMUS LOT S3 AND S4 ON A VIVA-E® ANALYZER. THE LIMITATIONS SECTION OF THE SYVA® EMIT® 2000 TACROLIMUS ASSAY INSTRUCTIONS FOR USE (IFU) STATES: "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS INVESTIGATING. NOTE: A SEPARATE MDR WILL BE SUBMITTED FOR SYVA® EMIT® 2000 TACROLIMUS LOT S4.

Description of Event or Problem

THE CUSTOMER REPORTED NON-REPRODUCIBLE SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER WHEN USING TACROLIMUS LOTS S3 AND S4. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH RESULT IS CONSIDERED CORRECT. IT IS UNKNOWN IF THE PATIENTS WERE TAKING TACROLIMUS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REPRODUCIBLE RESULTS.