BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMIT 2000 GENTAMICIN PLUS ASSAY

    MDR report key: 6504523 · Received April 19, 2017

    Report

    Report Number
    2517506-2017-00409
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    March 27, 2017
    Report Date
    June 16, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LCD
    PMA / PMN Number
    K962519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS REGIONAL SUPPORT CENTER (RSC) INVESTIGATED THE CAUSE OF THE DISCORDANT, ELEVATED GENTAMICIN RESULT ON THE VIVA-E ANALYSER INSTRUMENT. THE CAUSE OF THE DISCORDANT HIGH GENTAMICIN RESULT WAS DUE TO RUNNING A SAMPLE CONTAINING LOW LEVELS OF GENTAMICIN FOLLOWING A SAMPLE CONTAINING ELEVATED LEVELS OF GENTAMICIN. THE CUSTOMER WAS RUNNING 20 SAMPLES AND PROCESSED THE AFFECTED SAMPLE AFTER PROCESSING ANOTHER PATIENT SAMPLE HAVING AN EXTREMELY HIGH GENTAMICIN VALUE (165.0 UG/ML). THE GENTAMICIN PLUS ASSAY APPLICATION SHEET DEMONSTRATES THAT THIS CIRCUMSTANCE CAN POTENTIALLY CAUSE CARRYOVER. SIEMENS RSC PROVIDED THE INFORMATION FROM THE GENTAMICIN APPLICATION SHEET, WHICH THE CUSTOMER ALREADY HAD ACCESS TO AND WHICH STATES: "CARRYOVER CAN OCCUR WITH THIS ASSAY WHEN A NEGATIVE SAMPLE OR A SAMPLE CONTAINING LOW LEVELS OF GENTAMICIN IS ASSAYED FOLLOWING A SAMPLE CONTAINING ELEVATED LEVELS OF DRUG". SIEMENS ATTEMPTED TO OBTAIN THE LOT NUMBER AND EXPIRATION DATE OF THE AFFECTED GENTAMICIN REAGENT AND THE CUSTOMER HAS REFUSED TO PROVIDE THE INFORMATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2517506-2017-00409) ON APRIL 19, 2017. JUNE 16, 2017 CORRECTED INFORMATION: THE INFORMATION PROVIDED IN MANUFACTURER INFO IN THE ORIGINAL MDR IS INCORRECT AND THIS PART HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED GENTAMICIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE VIVA-E ANALYSER INSTRUMENT. THIS RESULT WAS PROVIDED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAME PATIENT SAMPLE WAS REPEATED THE NEXT DAY ON THE SAME VIVA-E ANALYSER INSTRUMENT AND RECOVERED WITHIN THE EXPECTED PATIENT RANGE. THE RE-RUN RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED GENTAMICIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284642 EMIT 2000 GENTAMICIN PLUS ASSAY EMIT 2000 GENTAMICIN PLUS ASSAY LCD SIEMENS HEALTHCARE DIAGNOSTICS INC. EMIT 2000 GENTAMICIN PLUS ASSAY

    Patients

    Seq Age Sex Outcome Treatment
    1