BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA EMIT AMIKACIN ASSAY

    MDR report key: 22496845 · Received July 14, 2025

    Report

    Report Number
    2517506-2025-00109
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    April 21, 2025
    Report Date
    October 27, 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 UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED OUT OF RANGE ON THE DAY AFTER THE ERRONEOUS RESULT WAS OBTAINED. THE ASSAY WAS RECALIBRATED, AFTER WHICH QC RECOVERED IN RANGE. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2025-00109 ON 14-JUL-2025. ADDITIONAL INFORMATION (13-OCT-2025): SIEMENS HAS REVIEWED THE INSTRUMENT DATA. THE ISSUE WAS RESOLVED WITH THE REPLACEMENT OF THE REAGENT AND SAMPLE MIXERS AND REPLACEMENT OF THE REACTION CUVETTES AS PART OF ROUTINE SERVICE TROUBLESHOOTING AND MAINTENANCE. THE CUSTOMER HAS BEEN MONITORED FOR REOCCURRENCE BY THE LOCAL TEAM SINCE AUGUST AND THERE HAS BEEN NO REPORTED RECURRENCE FROM THE CUSTOMER. SIEMENS HAS RECEIVED VERBAL CONFIRMATION FROM THE LOCAL SERVICE THE EVENT WAS RESOLVED WITH THE MAINTENANCE PERFORMED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED EVENT IS RESOLVED BY ROUTINE / SERVICE PART REPLACEMENT. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    A FALSELY LOW AMIKACIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 SYSTEM USING SYVA EMIT AMIKACIN REAGENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). AFTER QUALITY CONTROLS (QC) RECOVERED OUT OF RANGE THE FOLLOWING DAY, THE INITIAL AMIKACIN RESULT WAS QUESTIONED, AND THE SAMPLE WAS REPEATED FOR AMIKACIN AND RECOVERED HIGHER. THE HIGHER RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400662 SYVA EMIT AMIKACIN ASSAY RADIOIMMUNOASSAY, AMIKACIN KLQ SIEMENS HEALTHCARE DIAGNOSTICS INC. SYVA EMIT AMIKACIN ASSAY S2 00842768001543

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male