BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7106504 · Received December 11, 2017

    Report

    Report Number
    8031673-2017-00160
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 11, 2017
    Report Date
    August 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE DISPATCHED DATE WAS 13-NOV-2017. THE CORRECTED DATE IS 11-NOV-2017. IN SECTION G5 510K NUMBER FOR THE ADVERSE EVENT TERM WAS K071132. THE CORRECTED 510K FOR THE ADVERSE EVENT TERM IS K131580.

    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 13-NOV-2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER'S FACILITY. UPON ARRIVAL, FSE OBSERVED THAT SOME OF THE WHITE TOSOH RACKS WERE MISSING SPRINGS INSIDE AND SOME WERE CRACKED. THESE DEFECTIVE RACKS WERE DISPOSED OF. THE ALIGNMENT TO SAMPLE LOADER WAS VERIFIED FOR PROPER FUNCTION. CUSTOMER REPLACED THE SAMPLE NEEDLE AND RAN SEVERAL RACKS TO VERIFY. FSE MADE ADJUSTMENTS TO THE X1-960F PAR (245-265) TO BRING PUSH FOOT CLOSER TO ALIGNMENTS FOR TUBE. FSE RAN QUALITY CONTROLS AND ALL RESULTED WITHIN SPECIFICATIONS. NO FURTHER ACTION WAS REQUIRED. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL (B)(4) FROM 11-OCT-2016 THROUGH 11-NOV-2017. THERE WAS ONE OTHER SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 3, ASSAY OPERATIONS, UNDER CAUTION PROVIDES INFORMATION FOR PROPER USE: IF THE PRIMARY TUBES ARE LOOSE ON THE TOSOH RACK, ADJUST THE RACK'S HOLDER TO TIGHTLY HOLD THE PRIMARY TUBES. THE SAMPLING NEEDLE COULD BE BENT IF THE TUBES ARE LOOSE. INSERT THE PRIMARY TUBE STRAIGHT INTO THE RACKS. IF THE PRIMARY TUBE IS NOT SET STRAIGHT OR ITS BOTTOM IS NOT FIT TO THE RACK, THE SAMPLING NEEDLE COULD BE BENT. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO BROKEN RACK SPRING AND MISALIGNMENT.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED BROKEN SAMPLE PROBE ON THE G8 INSTRUMENT. THE CUSTOMER REPORTED NO ISSUES WHEN RUNNING QUALITY CONTROLS IN TEST CUPS, BUT WHEN THE SAMPLES WERE RUN IN THE FIRST PURPLE TUBE, THE RACK JAMMED. CUSTOMER NOTED THAT THE SAMPLE PROBE BENT AND BECAME STUCK IN THE RUBBER STOPPER OF THE PURPLE TUBE, WHICH WAS NOT HIGH IN THE RACK. CUSTOMER STATED USED THE TOSOH WHITE RACK. ON 13-NOV-2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C). THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885840 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1