BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH G8 AUTOMATED HPLC ANALYZER

    MDR report key: 2253744 · Received September 8, 2011

    Report

    Report Number
    3005529799-2011-00015
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 8, 2011
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    LCP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TOSOH G8 REPORTED ERRONEOUSLY LOW SA1C RESULTS ON PTS WITH HGBC VARIANTS. THE VARIANTS WERE CONFIRMED BY ANOTHER METHOD BUT TOSOH CHROMATOGRAPHY DID NOT INDICATE HV2 % FOR HGBC. RESULTS DID NOT CORRELATE WITH PREVIOUS RESULTS FOR PTS OR REFERENCE LAB RESULTS. ONE ERRONEOUS RESULT HAD BEEN REPORTED BUT NO TREATMENT WAS DONE BASED ON THE ERRONEOUS RESULTS. THE INVESTIGATION INTO THE ROOT CAUSE OF THE ERRONEOUS RESULTS INDICATED THAT ON (B)(6) 2011 AN INCORRECT VALUE HAD BEEN MANUALLY ENTERED DURING A SERVICE CALL FOR ONE OF THE G8 IDT PARAMETERS WHICH RESULTED IN THE INCORRECT RESULTS. ONCE THE IDT PARAMETER WAS CORRECTED THE TOSOH CHROMATOGRAPHY RESULTS CORRELATED WITH THE EXPECTED RESULTS AND OTHER METHODOLOGY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSOH G8 AUTOMATED HPLC ANALYZER AUTOMATED HPLC ANALYZER LCP TOSOH HI-TEC, INC. G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other