BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA® EMIT

    MDR report key: 2736611 · Received September 10, 2012

    Report

    Report Number
    2517506-2012-00231
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 14, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    KLQ
    PMA / PMN Number
    K822657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE IMPRECISE AMIKACIN RESULTS IS UNKNOWN. INSTRUMENT DATA INDICATED THAT PATIENTS WERE REPORTED WHILE QC WAS OUTSIDE OF IN-HOUSE RANGES. XAMIK IS AN OPEN CHANNEL REAGENT (I.E. FLEX PREPARED BY CUSTOMER). THE DIMENSION VISTA INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    IMPRECISE AMIKACIN RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN WHILE QC WAS OUT OF RANGE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF IMPRECISE AMIKACIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYVA® EMIT SYVA® EMIT AMIKACIN ASSAY KLQ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1