BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 5343344 · Received January 5, 2016

    Report

    Report Number
    3005529799-2015-00013
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 18, 2015
    Report Date
    April 17, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: HEALTH PROFESSIONAL. DATE RECEIVED BY MANUFACTURER: 21-DEC-2015. 510K: K071132. TYPE OR REPORT: FOLLOW-UP #: 1. TYPE OF REPORTABLE EVENT: MALFUNCTION. IF FOLLOW-UP, WHAT TYPE: CORRECTION, ADDITIONAL INFORMATION . DEVICE EVALUATED BY MFR: YES. (B)(4). USAGE OF DEVICE: REUSE. REVIEW OF THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL INFORMS THE USER THAT IT IS VERY IMPORTANT THAT THE OPERATOR REVIEW THE CHROMATOGRAMS BEFORE REPORTING RESULTS. SECTION 5 OF THE MANUAL DISCUSSES INTERPRETING RESULTS SO THAT THE OPERATOR WILL BE ABLE TO IDENTIFY A NORMAL CHROMATOGRAM, UNDERSTAND REPORTABLE VS. NON-REPORTABLE RESULTS, AND IDENTIFY WHEN TO REPEAT A SAMPLE. (B)(4), PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4).

    Description of Event or Problem · 0

    ON 21-DEC-2015, TOSOH BIOSCIENCE WAS NOTIFIED THAT FOUR (4) PATIENT SPECIMENS TESTED FOR HBA1C ON THE TOSOH G8 ANALYZER HAD INCORRECT RESULTS REPORTED ON (B)(6) 2015. ONE OF THE SPECIMENS HAD BEEN REPORTED AS 6.5% AND THE PHYSICIAN QUESTIONED THE RESULT SINCE THE HBA1C PATIENT RESULTS ON (B)(6) 2015 WAS 7.55%. THE SPECIMEN WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 7.3%. TOSOH TECHNICAL SUPPORT (TTS) REQUESTED THE CUSTOMER FAX A COPY OF THE CHROMATOGRAMS FOR REVIEW. AFTER EVALUATION OF THE CHROMATOGRAMS, TTS NOTED THAT THE BASELINE WAS ELEVATED ON THE ORIGINAL PRINTOUT OF THE 6.5% RESULT, AND WHEN REPEATED ON (B)(6) 2015 THE BASELINE WAS NORMAL WITH A RESULT OF 7.3%. DUE TO THESE FINDINGS, TTS ASKED THE CUSTOMER TO REVIEW ALL CHROMATOGRAMS FROM (B)(6) 2015. ALL THIRTY-THREE (33) PATIENT SPECIMENS TESTED ON (B)(6) 2015 WERE RERUN ON (B)(6) 2015. THE CHROMATOGRAMS FROM (B)(6) 2015 TESTING WERE REVIEWED AND FOUR (4) SPECIMENS ALL HAD INCREASED BASELINES AND UNACCEPTABLE CHROMATOGRAMS INDICATING THAT THE RESULTS SHOULD NOT HAVE BEEN REPORTED. THE CUSTOMER SENT OUT CORRECTED REPORTS FOR THE FOUR (4) PATIENT SPECIMENS THAT SHOULD NOT HAVE BEEN REPORTED. ON (B)(6) 2015, PREVENTIVE MAINTENANCE WAS PERFORMED ON THIS G8 ANALYZER, AND THE FOLLOWING WAS FOUND: COLUMN COUNT 1006, FILTER COUNT 102, RETENTION TIME 0.57 AND FLOW FACTOR 1.07. A TOSOH FIELD SERVICE ENGINEER (FSE) CALLED THE CUSTOMER TO DETERMINE WHAT COULD BE CAUSING THE ELEVATED BASELINES. THE FSE HAD THE CUSTOMER INSPECT THE INSTRUMENT FOR LEAKS AND NO LEAKS WERE FOUND. THE CUSTOMER WAS ALSO ASKED TO DO A DRAIN FLUSH TO GET RID OF ANY AIR IN THE LINES. FOLLOWING THE DRAIN FLUSH, THE PROBLEM SEEMED TO BE RESOLVED. ON (B)(6) 2015, THE CUSTOMER CALLED TO REPORT THAT NO FURTHER ELEVATED BASELINES OCCURRED SINCE (B)(6) 2015.

    Description of Event or Problem · 1

    (B)(6) 2015 TOSOH BIOSCIENCE WAS NOTIFIED THAT 4 SPECIMENS TESTED FOR HBA1C ON THE TOSOH G8 ANALZYER HAD INCORRECT RESULTS REPORTED ON (B)(6) 2015. ONE OF THE SPECIMENS HAD BEEN REPORTED AS 6.5% AND THE PHYSICIAN QUESTIONED THE RESULT SINCE A (B)(6) 2015 HBA1C RESULT ON THE PATIENT HAD BEEN 7.55%. THE SPECIMEN WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 7.3%. 33 SPECIMENS HAD BEEN TESTED SO WERE PULLED AND RETESTED. IN ADDITION TO THE INTIAL INCORRECT RESULT 3 OTHER SPECIMEN RESULTS DID NOT CORRELATE AND CORRECTED REPORTS WERE ISSUED. THE CHROMATOGRAMS FROM THE (B)(6) 2015 TESTING WERE REVIEWED AND THE FOUR SPECIMENS ALL HAD INCREASED BASELINES AND WERE NOT ACCEPTABLE CHROMATOGRAMS SO SHOULD NOT HAVE BEEN REPORTED. A TOSOH BIOSCIENCE FSE WAS DISPATCHED TO DETERMINE IF THERE WERE ANY ANALYZER ISSUES CAUSING THE ELEVATED BASELINES. ROOT CAUSE: AIR IN TUBING CAUSED ANALYZER INCORRECT RESULTS. INCORRECT RESULTS SHOULD HAVE BEEN IDENTIFIED DURING CHROMATOGRAM REVIEW BEFORE RESULTS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4499 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other STRECK QUALITY CONTROLS