BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 6889197 · Received September 24, 2017

    Report

    Report Number
    8031673-2017-00033
    Event Type
    Malfunction
    Date Received
    September 24, 2017
    Date of Event
    August 24, 2017
    Report Date
    January 9, 2018
    Manufacturer
    TOSOH HI-TEC
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: DEVICE EVALUATION BY MANUFACTURER: THE REPORTED LOW TOTAL AREA ON PATIENT SAMPLES WAS ATTRIBUTED TO AN OBSTRUCTED SAMPLING NEEDLE ASSEMBLY.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. CORRECTED DATA: H.3. DEVICE EVALUATION BY MANUFACTURER: THE REPORTED LOW TOTAL AREA ON PATIENT SAMPLES WAS ATTRIBUTED TO AN OBSTRUCTED SAMPLING NEEDLE ASSEMBLY.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    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: ON 25-AUG-2017 A FIELD SERVICE ENGINEER (FSE) FOUND THE SAMPLE NEEDLE ASSEMBLY OBSTRUCTED. THE FSE REPLACED THE SAMPLE NEEDLE ASSEMBLY, RAN QUALITY CONTROLS, AND PATIENT SAMPLES. THE G8 SYSTEM WAS RUNNING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(6) FOUND TWO (2) SIMILAR COMPLAINTS DURING THIS TIME PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1 - INTRODUCTION AND APPLICATIONS, SECTION 1.8 LIMITATIONS OF THE PROCEDURE, STATES THAT DILUTION STUDIES DEMONSTRATE THAT THE ASSAY IS LINEAR FROM A TOTAL AREA OF 500 TO 4000. HOWEVER, THE OPTIMUM TOTAL AREA IS 700 TO 3000. THE REPORTED HIGH RETENTION TIME ON PATIENT SAMPLES WAS ATTRIBUTED TO THE FLOW FACTOR REQUIRING ADJUSTMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING SPORADIC LOW TOTAL AREA IN PATIENT SAMPLES RANGING FROM 200 TO 300, WHICH UPON REPEAT WERE 1200 TO 1800 (NORMAL RANGE 500 - 4000). TOTAL AREA ON QUALITY CONTROLS WAS LOW AS WELL. THE NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT PROVIDED. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669013 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH HI-TEC G8

    Patients

    Seq Age Sex Outcome Treatment
    1