BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA EMIT AMIKACIN ASSAY

    MDR report key: 17798263 · Received September 22, 2023

    Report

    Report Number
    1219913-2023-00203
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 29, 2023
    Report Date
    February 18, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KLQ
    UDI-DI
    00842768001543
    PMA / PMN Number
    K822657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITES STATES (OUS) CUSTOMER OBTAINED A FALSELY ELEVATED SYVA EMIT AMIKACIN (AMIK), LOT R2, PATIENT RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL (DILUTED) RESULT WAS DISCORDANT COMPARED TO THE REPEAT DILUTED RESULTS TESTED ON THE SAME ANALYZER. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "SAMPLES CONTAINING AMIKACIN IN COMBINATION WITH KANAMYCIN CANNOT BE RELIABLY QUANTITATED BY THIS ASSAY." "WHEN DILUTING PATIENT SAMPLES CONTAINING HIGH AMIKACIN CONCENTRATIONS, THE FOLLOWING FACTORS CAN AFFECT THE ACCURACY OF THE RESULT: DILUTING WITH THE CORRECT FLUID (EMIT® AMIKACIN CALIBRATOR 0), AND THE ACCURACY OF THE DILUTION." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER COMPLAINT OF A FALSELY ELEVATED EMIT AMIKACIN (AMIK), PATIENT RESULT ON AN ATELLICA CH 930 ANALYZER. THE CUSTOMER WAS USING THE ASSAY IN THE USER DEFINED METHOD CHANNEL. THE OPEN CHANNEL AMIKACIN IN USE DEVIATES FROM THE VALIDATED PARAMETERS ONLY WITH THE ASSAY RANGE. THE CUSTOMER OPEN CHANNEL PARAMETERS HAS THE SYSTEM REPORTING IN MG/L INSTEAD OF THE RECOMMENDED STANDARD UNIT OF G/ML, THIS DIFFERENCE IN UNIT HAS A CONVERSION OF FACTOR OF 1 SO THERE IS NO EFFECT ON THE FINAL RESULTS BY THIS DEVIANCE FROM THE VALIDATED PARAMETERS, HOWEVER, THE CUSTOMER IS USING A LOWER ASSAY RANGE OF 20 MG/L COMPARED TO THE RECOMMENDED 50 G/ML CAUSING THE SYSTEM TO PERFORM AUTO-DILUTIONS ON SAMPLES GREATER THAN 20 MG/L (G /ML). THE DISCORDANT SAMPLE (SAMPLE ID 8156248887 OF 38 MG/L [¿G /ML]) APPEARS TO BE THE RESULT OF A SAMPLE INTEGRITY ISSUE AND NOT A RELATED TO THE QC ISSUE BEING REPORTED. THE SAMPLE PRODUCED THE FOLLOWING AMIKACIN RESULTS 28*, 38, 26*, 27, 26*, 26, AND 26 MG/L. THE RESULTS MARKED WITH THE * HAD THOSE VALUES SUPPRESSED AND REPORTED AS >20 MG/L DUE TO THE CUSTOMER REDUCING THE ASSAY RANGE FROM THE SIEMENS RANGE OF 2.5 ¿ 50 G /ML (MG/L) TO 2.5 ¿ 20 G /ML (MG/L). ALL THE RESULTS WERE GENERATED FROM THE SAME CALIBRATION, AND REAGENT PACK. WHILE SOME VARIATION CAN BE SEEN WHEN DILUTIONS ARE USED. THE 38 MG/L RESULT IS OUTSIDE OF NORMAL DILUTION VARIANCE. THE AUTO-DILUTION OF THE ANALYZER WAS CONFIRMED TO FUNCTION AS DESIGNED BASED ON THE PERFORMANCE OF THE REPEATS OF THE SAMPLE. NO ANALYZER ISSUE IS IDENTIFIED WITH THIS ISSUE. THE DISCORDANT RESULT WAS NOT REPEATABLE SO THERE IS NO EVIDENCE OF AN INTERFERENT. SIEMENS CANNOT RULE OUT SAMPLE INTEGRITY AS THE PROBABLE CAUSE AS DUE TO THE TRANSIENT NATURE OF SAMPLE INTEGRITY ISSUES, FURTHER EVALUATION OF THE SAMPLE AFTER THE ISSUE WOULD NOT BE ABLE TO VERIFY A SAMPLE INTEGRITY ISSUE. WHILE THE CAUSE OF THE DISCORDANCE IS SUSPECTED TO BE FROM SAMPLE HANDLING THAT CANNOT BE VERIFIED WITH THE AVAILABLE DATA. THIS IMPRECISION IS NOT RELATED TO DISCORDANT SAMPLE BASED ON THE MAGNITUDE OF THE DISCORDANCE COMPARED TO THE IMPRECISION OF THE QC. THE QC IMPRECISION SEEMS TO BE RELATED TO A REAGENT PACK TO PACK VARIANCE. THE AMIKACIN REAGENTS REQUIRE SIGNIFICANT REAGENT PREPARATION STEPS BY THE CUSTOMER BEFORE THE CUSTOMER FILLS THE REAGENT PACK. FAILURE TO FOLLOW THESE STEPS CAN CREATE THE IMPRECISION IDENTIFIED. SIEMENS HAS FOUND THE IMPRECISION ISSUE TO BE LOCALIZED TO THIS CUSTOMER AND NOT TO A SPECIFIC REAGENT LOT, OR CONTROL MATERIAL. NO ISSUE WITH THE ANALYZER PERFORMANCE WAS IDENTIFIED IN THE TECHNICAL EVALUATION. WHILE THE QC IMPRECISION ISSUE APPEARS TO BE DUE TO VARIANCE IN THE MANUAL REAGENT PREPARATION STEPS, THIS CANNOT BE VERIFIED WITH THE AVAILABLE DATA. BASED ON THE AVAILABLE INVESTIGATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. SIEMENS FILED MDR 1219913-2023-00203 INITIAL REPORT ON 21-SEP-2023. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    CUSTOMER OBTAINED A FALSELY ELEVATED SYVA EMIT AMIKACIN (AMIK), LOT R2, PATIENT RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL UNDILUTED SERUM SAMPLE RESULT WAS GREATER THAN THE ANALYTICAL MEASURING RANGE WHEN IT WAS TESTED NEAT AND DILUTED. THE INITIAL DILUTED RESULT WAS DISCORDANT COMPARED TO THE REPEAT DILUTED RESULTS TESTED ON THE SAME ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHAT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104983 SYVA EMIT AMIKACIN ASSAY RADIOIMMUNOASSAY, AMIKACIN KLQ SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A R2 00842768001543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown