BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH G8 AUTOMATED HPLC ANALYZER

    MDR report key: 5716655 · Received June 10, 2016

    Report

    Report Number
    3005529799-2016-00009
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 10, 2016
    Manufacturer
    TOSOH HI-TEC
    Product Code
    LCP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 05/20/2016 TOSOH BIOSCIENCE, INC. WAS NOTIFIED OF A DISCREPANCY FOR AN HBA1C RESULT THAT WHEN RUN STRAIGHT HAD A RESULT OF 8.1% BUT WHEN DILUTED 1:100 THE RESULT WAS 6.6%. THE PHYSICIAN REPORTED THAT THE 8.1% RESULT DID NOT CORRELATE WITH THE PATIENT CONDITION. ON (B)(6) 2016 THE SPECIMEN WAS REPEATED AND RUN STRAIGHT WITH A RESULT OF 8.7%. ON 05/25/2016 INFORMATION WAS FORWARDED TO TOSOH-(B)(4) FOR ADDITIONAL REVIEW AND ADDITIONAL INFORMATION THAT THE ANALYZER FILTER COUNT WAS 253 AND THE COLUMN COUNT WAS 474. ON 05/27/2016 TOSOH-(B)(4) INDICATED THAT THE SPECIFIC CHARACTERISTICS OF THE CHROMATOGRAMS WERE AS FOLLOWS: PEAK SEPARATION BETWEEN SA1C AND A0 PEAK WAS POOR. PEAK SEPARATION BETWEEN L-A1C+ AND SA1C PEAK WAS POOR. THE A0 PEAK WAS BROAD AND HAD A LEDGE IN FRONT SIDE OF THE A0 PEAK. THE G8 ANALYZER WAS FUNCTIONING AS EXPECTED. THE RECOMMENDATION WAS TO SET AN ADDITIONAL FLAG 07 TO CHECK THE SA1C PEAK SHAPE. MESSAGE FOR THIS FLAG IS "COLUMN CHECK" OR "TP LOW". THIS FLAG WILL INDICATE ANY COLUMN DETERIORATION AND THIS TYPE OF HB VARIANT WHEN THE SA1C PEAK BECOMES BROAD. ROOT CAUSE: HEMOGLOBIN E VARIANT NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371132 TOSOH G8 AUTOMATED HPLC ANALYZER G8 LCP TOSOH HI-TEC G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other