BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA® EMIT® 2000 TACROLIMUS ASSAY

    MDR report key: 18653729 · Received February 6, 2024

    Report

    Report Number
    2517506-2024-00055
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 18, 2024
    Report Date
    April 15, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MLM
    UDI-DI
    00842768001666
    PMA / PMN Number
    K060385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2024-00055 ON 06-FEB-2024. ADDITIONAL INFORMATION 21-MAR-2024: SIEMENS PERFORMED INITIAL TESTING AND REFERRED THE DATA FOR FURTHER REVIEW. ADDITIONAL INFORMATION 12-APR-2024: SIEMENS INVESTIGATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: THE EXPECTED BEHAVIOR OF THE SYVA® EMIT® 2000 TACROLIMUS ASSAY REAGENT IS AS FOLLOWS, INFORMATION SUMMARIZED BELOW CAN BE ATTAINED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), INSTRUMENT APPLICATION SHEET, AND VENDOR¿S CONTROL DOCUMENTATION. THE REAGENT IFU STATES THAT THE REAGENTS WILL REMAIN STABLE AFTER OPENING FOR 12 WEEKS OR UNTIL THE EXPIRATION DATE PRINTED ON THE LABEL (WHICHEVER IS SOONER), PENDING THAT THEY ARE STORED AT 2 ¿ 8°C, UPRIGHT, AND WITH CAPS TIGHTLY CLOSED. IFU STATES TO REFER TO APPLICATION SHEET FOR COMPLETE INSTRUCTIONS. APPLICATION SHEET STATES THAT REAGENTS MAY BE STORED ONBOARD, CAPPED WHEN NOT IN USE FOR UP TO 4 WEEKS OR AS QUALITY CONTROL (QC) RESULTS ARE WITHIN ACCEPTABLE LIMITS. QC EXPECTED RANGES ARE PROVIDED BY THE VENDOR, WITH THE EXPECTATION THAT INDIVIDUAL LABORATORIES WILL DEVELOP THEIR OWN QC RANGES USING THE EXPECTED RANGES AS A GUIDELINE. THE SYVA IFU ALSO PROVIDES INSTRUCTION FOR THE TESTING LABORATORY TO GENERATE THEIR OWN QC RANGES AND STATES THAT IN THE EVENT OF A QC FAILURE THE TESTING LABORATORY IS REQUIRED TO FOLLOW THE LABORATORY¿S QUALITY PROCEDURES. THE CUSTOMER IS ALLEGING INSTABILITY IN REAGENT OBSERVED BY QC RESULTS DRIFTING/FAILING LOW AND INCONSISTENT CLINICAL SAMPLE RESULTS. WHEN QC RESULTS DRIFT/FAIL LOW THE CUSTOMER IS REQUIRED TO RE-CALIBRATE AND TO PERFORM ADDITIONAL TROUBLESHOOTING. SINCE THE ATELLICA CH LOT 130034 CONTAINS THE SAME REAGENT USED IN THE SYVA EMIT 2000 TACROLIMUS REAGENT LOT S1 AND THE VIVA-PROE AND THE ATELLICA CH USE THE SAME PRINCIPLE OF SPECTROSCOPY TO MEASURE ANALYTE CONCENTRATION IN CALIBRATOR, CONTROL, OR PATIENT SAMPLE, SIEMENS PERFORMED TESTING USING THE ATELLICA CH REAGENT LOT 130034. THE PRINCIPLE OF SPECTROSCOPY USED IS BASED ON MEASURING THE ABSORBANCE OF LIGHT AT 340 DURING THE REACTION BETWEEN SAMPLE, REAGENT 1, AND REAGENT 2. SIEMENS' REVIEW OF THE ATELLICA CH DATA DID NOT CONFIRM THE OBSERVATIONS REPORTED BY THE CUSTOMER. THE SYVA EMIT 2000 TACROLIMUS ASSAY REAGENT HAS NO CALIBRATION INTERVAL CLAIMS AND THE VIVA-PROE APPLICATION SHEET INSTRUCTS THE OPERATOR TO ¿PREPARE A CALIBRATION CURVE WHENEVER A NEW LOT OF REAGENTS ARE USED OR AS INDICATED BY CONTROL RESULTS¿. THE PRODUCT PROBLEM IDENTIFIED BY THE CUSTOMERS IS NOT CONFIRMED. CUSTOMER SAMPLE HANDLING METHODS CANNOT BE RULED OUT AS A POTENTIAL RESULT IN ADVERSE ASSAY PERFORMANCE. THE SYVA EMIT 2000 TACROLIMUS ASSAY LOT S1 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT QUALITY CONTROL (QC) FAILURES AND FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS THAT WERE OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE SYSTEM. OTHER ASSAY RESULTS ON THE EQUIPMENT WERE NORMAL. THE EQUIPMENT IS MAINTAINED ON A DAILY BASIS. MAINTENANCE PERFORMED INCLUDES SYSTEM CLEANING, SYRINGE MAINTENANCE, ADJUSTMENT OF LIGHT PATH, AND DUST REMOVAL. THE FOLLOWING TROUBLESHOOTING STEPS WERE PERFORMED: SYSTEM CLEANING OF THE EQUIPMENT, CHECK 8ABS, REPLACEMENT OF NEW CONSUMABLE PARTS, REPLACEMENT OF NEWLY CONFIGURED CLEANING FLUID, HCL, AND NACLO, AMBIENT TEMPERATURE AND HUMIDITY CONTROL, ON-SITE OPERATION BY APPLICATION ENGINEERS, RECALIBRATION FOR QUALITY CONTROL. 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.

    Description of Event or Problem · 0

    FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE SYSTEM. RESULTS WERE INCONSISTENT WITH HISTORICAL RESULTS. FOR SOME OF THE PATIENT SAMPLES THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN IF THE PHYSICIAN(S) QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. A CORRECTED REPORT WAS ISSUED. ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR THE QC FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031874 SYVA® EMIT® 2000 TACROLIMUS ASSAY ENZYME IMMUNOASSAY, TACROLIMUS MLM SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A S1 00842768001666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown