BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7356477 · Received March 20, 2018

    Report

    Report Number
    8031673-2018-03912
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    September 15, 2016
    Report Date
    March 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE 15TH OF SEPTEMBER 2016 FOR FURTHER INVESTIGATION. THE FSE CONDUCTED A FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. DURING THE INVESTIGATION OVER THE PHONE THE FSE INSTRUCTED THE CUSTOMER TO DECONTAMINATE THE INSTRUMENT WITH 20% BLEACH AND A DUMMY COLUMN. THEN THE INSTRUMENT WAS FLUSHED AND REPLACED ALL REAGENTS. AFTER THE DECOMNTAMINATION PROCESS THE CUSTOMER RAN WHOLE BLOOD SAMPLES AND THE RESULTS DID NOT EXHIBIT ANY H-VARIENT PEAKS. WHEN THE FSE WENT ONSITE HE FOUND THE ALL THREE BUFFER BAGS WERE LOW AND AIR INSIDE OF THEM. FSE PURGED AIR FROM THE BAGS. ALSO, FSE REPLACED THE FILTER BECAUSE THE FILTER COUNT WAS 500. FSE TESTED PATIENT SAMPLES AND THE CHROMATOGRAM SHOWED UNIDENTIFIABLE PEAKS. THEN THE FSE AQUIRED TWO MORE SAMPLES FROM THE CUSTOMER TO RUN ON THE INSTRUMENT. 1 SAMPLE HAND NORMAL CHROMATOGRAM AND THE OTHER SAMPLE HAD ABOUT 13% H VARIENCE. A RERUN WAS PROFORMED FOR THE SAMPLE CONTAINING 13% VARIENCE ON ANOTHER G8 INSTRUMENT AND SHOWED SIMILAR RESULTS. THE FSE THEN RAN 10 MORE SAMPLES ON BOTH ANALYZERS AND ALL THE CHROMATORGRAMS WERE WITHIN NORMAL RANGE AND SHOWED NO ERRORS. INSTRUMENT IS RELEASED AND FUNCTIONING AS INTENDED. THE MOST PROBABLE CAUSE FOR THIS EVENT IS DUE TO CONTAMINATION OF THE DEVICE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED RECEIVING HEMOGLOBIN VARIANT PEAKS. THE CHROMATOGRAMS WERE FAXED TO THE TECHNICAL SUPPORT GROUP (TSG) AND VERIFIED CLIENT IS RECEIVING NON-SPECIFIC HEMOGLOBIN VARIANT PEAKS ON THERE CHROMATOGRAMS OF 12-17%. THE RETENTION TIME WAS 1.16. THE CUSTOMER INDICATED THAT THE COLUMN IS A NEW ONE AND IT HAD THE SAME H-VARIANT PEAKS. TSG REQUESTED THE CUSTOMER TO REPLACE THE BUFFERS AND HEMOLYSIS AND WASH SOLUTION WITH NEW ONES. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195200 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1