BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6792860 · Received August 14, 2017

    Report

    Report Number
    8031673-2017-00006
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    January 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    TOSOH HI-TEC
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 27-DEC-2015 THROUGH 27-JAN-2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE CUSTOMER'S SAMPLE IN TOSOH'S QA LAB CONFIRMED THE CUSTOMER'S RESULTS. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THAT THE LEVEL OF LA1C CHANGES RAPIDLY IN RESPONSE TO CHANGES IN BLOOD GLUCOSE CONCENTRATION. HOWEVER, THE LEVEL OF THE SA1C DOES NOT FLUCTUATE SIGNIFICANTLY IN RESPONSE TO PHYSIOLOGICAL FACTORS. CONSEQUENTLY, THE SA1C MEASUREMENT PROVIDES A BETTER INDICATION OF THE AVERAGE GLUCOSE LEVEL OVER THE PREVIOUS TWO TO THREE MONTHS (THE AVERAGE RED BLOOD CELL LIFE SPAN). A REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER SHOWED THAT THE COLUMN COUNT WAS AT 3001 INJECTIONS, WHICH EXCEEDED THE 2500 INJECTION COUNT RECOMMENDED BY TOSOH BIOSCIENCE, INC. ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXCEPTION NUMBER E2017013.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE CUSTOMER REPORTED RESULTS FOR SA1C OF 5.2%, LA1C OF 5.1 % (ABOVE REPORTABLE RANGE), AND GLUCOSE OF 244 MG/DL. THE CUSTOMER REPORTED THAT THE NORMAL SA1C RESULT OF 5.2% DID NOT MATCH THE PATIENT'S CLINICAL HISTORY, WHICH WAS TYPICALLY HIGHER. THE CUSTOMER WAS ADVISED TO SEND THE SPECIMEN FOR TESTING WITH AN ALTERNATIVE METHOD; THE SPECIMEN WAS SENT OUT TO BE TESTED ON ROCHE'S INTEGRA IMMUNOTURBOMETRIC METHODOLOGY. ON (B)(6) 2017 THE CUSTOMER REPORTED THAT THE TEST THAT WAS SENT OUT TO BE TESTED ON ROCHE'S INTEGRA IMMUNOTURBOMETRIC METHODOLOGY HAD A SA1C RESULT OF 8.4%. THE CUSTOMER PROVIDED THE CHROMATOGRAMS AND UPON REVIEW IT WAS DETERMINED THAT FURTHER TESTING BY TOSOH'S QUALITY ASSURANCE (QA) LAB WOULD BE REQUIRED. THE PATIENT WAS CURRENTLY ON THE FOLLOWING MEDICATION: BETAMETHASONE - DIPROPIONATE, OMBIVENT RESPIMAT, METFORMAN HCG EXTENDED RELEASE, PRO-AIR HFA 108, SIMBACORT, LIDOCAINE MOUTH RINSE. THE CUSTOMER CONFIRMED THAT THE SA1C OF 5.2% RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN, BECAUSE IT WAS INCONSISTENT WITH THE PATIENT'S PROFILE. ON (B)(6) 2017 THE CUSTOMER CALLED BACK TO DISCUSS TOSOH'S QA LAB FINDINGS, WHICH CONFIRMED THAT THE SPECIMEN RAN IN QC CORRELATED WITH THEIR RESULT. THE CUSTOMER DID QUESTION WHY THERE WAS A DIFFERENCE WITH THE INTEGRA IMMUNOTURBOMETRIC METHODOLOGY. THE CUSTOMER STATED THAT THE PATIENT HAS NOT BEEN IN THE CLINIC AGAIN FOR ANOTHER HA1C TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573059 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH HI-TEC G8

    Patients

    Seq Age Sex Outcome Treatment
    1