BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7988243 · Received October 20, 2018

    Report

    Report Number
    8031673-2018-00969
    Event Type
    Malfunction
    Date Received
    October 20, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 ON SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE ACCURACY AND PRECISION OF THE ANALYTICAL PERFORMANCE, CONTROLS SHOULD BE ASSAYED DAILY AND AFTER COLUMN REPLACEMENT. TOSOH SUGGESTS RUNNING AT LEAST TWO LEVELS OF QUALITY CONTROL MATERIAL. THE MEAN OF ONE SHOULD BE IN THE NON-DIABETIC RANGE (4-7% HBA1C) WITH THE SECOND IN THE RANGE OF 9-12% HBA1C. IF THE VALUE OF ONE OR MORE CONTROL SPECIMENS IS OUT OF THE ACCEPTABLE RANGE, RECALIBRATE THE SYSTEM AND RERUN THE CONTROLS BEFORE TESTING PATIENT SAMPLES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DUPLICATED. THE ISSUE RESOLVED AFTER THE CUSTOMER RECEIVED A NEW SET OF PROPERLY-LABELED SAMPLES FROM AMERICAN PROFICIENCY INSTITUTE (API).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY FAILED THE THIRD HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) EVENT OF THE AMERICAN PROFICIENCY INSTITUTE (API) SURVEY SAMPLES ON THE G8 INSTRUMENT. THE CUSTOMER REPEATED THE SAMPLES AND GOT A SIMILAR RESULT. THE RESULTS OF THE SURVEY WERE: GLY-14: 9.1%, REPEAT 12.0%, GLY-15: 11.8%, REPEAT 8.9%. THE CUSTOMER USED NEW SAMPLES RECEIVED FROM API AND WAS ABLE TO PASS THE SURVEY. THE CUSTOMER WAS TOLD BY API THAT THERE HAD BEEN A KNOWN MISLABELING ISSUE. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO DISCREPANT API SURVEY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828646 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1