BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7351434 · Received March 19, 2018

    Report

    Report Number
    8031673-2018-03200
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    December 14, 2015
    Report Date
    March 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2015, AN FSE CONDUCTED TROUBLESHOOTING OVER THE PHONE WITH THE CUSTOMER TO ADDRESS THE REPORTED EVENT. THE CUSTOMER WAS ASKED TO REPLACE THE COLUMN BUT THE TECH AT THE FACILITY WAS NOT FAMILIAR WITH THE PROCESS. THE CUSTOMER STATED THE COLUMN WILL BE CHANGED IN THE MORNING BY ANOTHER TECH. THE NEXT DAY, THE FSE CALLED BACK TO ASSIST THE CUSTOMER WITH FLUSHING OUT THE SYSTEM AND THE CUSTOMER REPORTED NORMAL RETENTION TIMES WITH NO ABNORMAL PEAKS. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THE G8 ANALYZER WAS FUNCTIONING AS INTENDED AND THE ISSUE CLEARED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS PEEK TUBING. TOSOH BIOSCIENCE, INC. IS SUBMITTNG 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).

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED HIGHER THAN NORMAL RETENTION TIMES WITH THEIR G8 ANALYZER. THE CUSTOMER TRIED ADJUSTING THE FLOW RATE BUT DID NOT SEE ANY IMPROVEMENT IN THE RETENTION TIMES. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192474 TOSOH HLC-723G8 ANALYZER G8 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1