BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6219593 · Received January 3, 2017

    Report

    Report Number
    3005529799-2016-00019
    Event Type
    Injury
    Date Received
    January 3, 2017
    Date of Event
    December 15, 2016
    Report Date
    April 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA/ ADDL INFORMATION: PATIENT IDENTIFIER, ADVERSE EVENT OR PRODUCT PROBLEM, OUTCOMES ATTRIBUTED TO ADVERSE EVENT, DATE OF EVENT, EVENT,RELEVANT TESTS/LABORATORY DATA, BRAND NAME, MANUFACTURER NAME, CITY AND STATE, OPERATOR OF DEVICE, INITIAL REPORTER HEALTH PROFESSIONAL, INITIAL REPORTER OCCUPATION, E4, F3, F4, F5, F6, F11, F12, F14. MFR SITE 2: CONTACT OFFICE: (B)(4) G1, 2: MANUFACTURING SITE: TOSOH CORPORATION (MANUFACTURER) SHIBA-KOEN (B)(4) G7: FOLLOW UP #1 H1: MALFUNCTION H2. CORRECTION H3: YES H4, 08/01/2011 H5. NO H6: PATIENT CODE: 2692; NO KNOWN IMPACT OR CONSEQUENCE TO PAIENT DEVICE CODE: 2456; INCORRECT OR INADEQUATE TEST RESULTS METHOD CODE:3263; ACTUAL DEVICE NOT EVALUATED RESULTS CODE:114; OPERATIONAL PROBLEM CONCLUSION CODE: 19; HUMAN FACTORS ISSUE H8: REUSE H10. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO OPERATOR ERROR. 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(B)(4). 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 CALLED TO REPORT LOW PATIENT HBA1C RESULTS (3.6%) ON THEIR G8 ANALYZER. THE SPECIMEN WAS REPEATED AND THE RESULT WAS (B)(4) , WHICH WAS EXPECTED BASED ON PREVIOUS RESULTS. THE REPORTED RESULT WAS MODIFIED AFTER RECEIVING THE SECOND RESULT. THE COLUMN COUNT AND QUALITY CONTROL (QC) WERE REPORTED TO BE WITHIN ACCEPTABLE RANGES. NO INTERVENTION WAS PERFORMED; HOWEVER, TECHNICAL SUPPORT (TS) RECOMMENDED THAT THE CUSTOMER USE RECOMMENDED FLAGS (AUTO-VERIFY) AND THAT THEY REVIEW ALL CHROMATOGRAMS PRIOR TO REPORTING. TS FAXED THE CUSTOMER A LIST OF RECOMMENDED FLAGS FOR FUTURE REFERENCE. THE REPORTED EVENT RESULTED IN DISCREPANT HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016: TOSOH BIOSCIENCE WAS NOTIFIED THAT AN HBA1C RESULT FROM THE TOSOH BIOSCIENCE G8 ANALYZER HAD BEEN REPORTED AS A RESULT OF 3.6%. THE COLUMN COUNT (2463) WAS WITHIN ACCEPTABLE RANGE AND THE QCS WERE ACCEPTABLE. THE ANALYZER WAS PERFORMING AS EXPECTED. THE SPECIMEN WAS REPEATED AND THE RESULT WAS 8.1%, WHICH WAS EXPECTED BASED ON PREVIOUS RESULTS. NO TREATMENT WAS PERFORMED BASED ON THE INITIAL LOW RESULT. THE INVESTIGATION OF THE INCORRECT RESULT INDICATED THAT THE CUSTOMER USES AUTO VERIFICATION OF RESULTS AND THE CHROMATOGRAMS ARE NOT REVIEWED. THE CHROMATOGRAM FOR THE INCORRECT RESULT HAD A SHOULDER ATTACHED TO THE A0 PEAK WHICH IF REVIEWED SHOULD HAVE INDICATED A NON-REPORTABLE RESULT. TOSOH BIOSCIENCE RECOMMENDS A REVIEW OF THE CHROMATOGRAMS BEFORE RESULTS ARE REPORTED. ROOT CAUSE: OPERATOR ERROR. CHROMATOGRAM WAS NOT REVIEWED PRIOR TO RESULT BEING RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3002 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other