BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMIT AMIKACIN ASSAY

    MDR report key: 12961443 · Received December 8, 2021

    Report

    Report Number
    2517506-2021-00338
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 8, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KLQ
    UDI-DI
    00842768001543
    PMA / PMN Number
    K822657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER. THE CUSTOMER IDENTIFIED AND CONFIRMED THAT THE CALIBRATOR LEVELS 5 AND 6 FOR THE EMIT AMIKACIN ASSAY WERE MISLABELED BY THE CUSTOMER AND WAS USED TO CALIBRATE THE ASSAY. AFTER OBTAINING THE DISCORDANT RESULTS, THE OPERATOR SUBSEQUENTLY PROPERLY LABELLED THE CALIBRATORS AND PREPARED NEW CALIBRATION TO OBTAIN ACCEPTABLE CALIBRATION. MISLABELING OF CALIBRATORS WAS A USE ERROR. THE REAGENT AND INSTRUMENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THESE DEVICES IS REQUIRED.

    Description of Event or Problem · 0

    A PATIENT SAMPLE WAS INITIALLY PROCESSED FOR AMIKACIN ON AN ATELLICA CH 930 ANALYZER USING THE EMIT AMIKACIN ASSAY, AND THE SAMPLE RECOVERED 50 UG/ML. THE INITIAL RESULT WAS CONSIDERED DISCORDANT AND WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS MANUALLY DILUTED USING THE LEVEL 0 CALIBRATOR AND REPEATED TWICE ON THE SAME INSTRUMENT AND THE SAMPLE RECOVERED LOWER. THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THAT THEY SENT A RECOMMENDATION TO RECOLLECT THE SAMPLE AS THE AFFECTED SAMPLE WAS NOT SUFFICIENT FOR RETESTING. THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN AND THE CUSTOMER DOES NOT RECALL WHETHER THE PATIENT WAS REDRAWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AMIKACIN RESULT(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862218 EMIT AMIKACIN ASSAY EMIT AMIKACIN ASSAY KLQ SIEMENS HEALTHCARE DIAGNOSTICS INC. EMIT AMIKACIN ASSAY N2 00842768001543

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown