BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8192993 · Received December 22, 2018

    Report

    Report Number
    8031673-2018-05346
    Event Type
    Malfunction
    Date Received
    December 22, 2018
    Date of Event
    November 28, 2018
    Report Date
    December 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. FSE ARRIVED ON SITE TO ADDRESS THE REPORTED EVENT. FIRST, FSE VERIFIED THE ERROR BY TURNING ON THE PUMP AND VERIFYING THAT THE PRESSURE EXCEEDS THE ALLOWABLE RANGE. FSE REPLACED THE TUBING FROM POSITION 6 ON THE INJECTOR VALVE TO THE BOTTOM OF THE PRE-FILTER ASSEMBLY AND RAN THE PUMP. THE PRESSURE WAS NOW IN RANGE, RUNNING AT 9.5 MPA. FSE WAS SUBSEQUENTLY ABLE TO RUN QUALITY CONTROL (QC) AND TWENTY PATIENT SAMPLES WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM 28OCT2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE FOUR SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6- TROUBLESHOOTING AND CHAPTER 1- INTRODUCTION & APPLICATIONS STATE THE FOLLOWING: WHEN CONSULTING WITH TECHNICAL SUPPORT ABOUT A PROBLEM, PLEASE NOTE THE ERROR MESSAGE AND ERROR NUMBER. IN ADDITION, IF YOU FOLLOW THE SUGGESTED SOLUTIONS IN THIS SECTION AND ARE STILL UNABLE TO RESOLVE THE ERROR, OR IF YOU ENCOUNTER AN ERROR MESSAGE THAT IS NOT NOTED, CONTACT TECHNICAL SUPPORT. GENERAL ERROR MESSAGES: WITH THESE ERRORS, THE ASSAY STOPS AND THE ANALYZER IMMEDIATELY ENTERS STAND-BY STATE. 100 PRESSURE HIGH: THE PUMP PRESSURE EXCEEDED THE UPPER LIMIT (15 MPA) SET IN THE PRES HIGH PARAMETERS. WHEN THE FILTER OR COLUMN REPLACEMENT PERIOD HAS BEEN EXCEEDED, FIRST REPLACE THE FILTER OR COLUMN. IF THE PRESSURE IS STILL HIGH, REMOVE THE INLET AND OUTLET FLOW LINE AROUND THE COLUMN AND FILTER, AND DETERMINE WHICH PART IS THE CAUSE OF THE HIGH PRESSURE. THEN, CONTACT A TECHNICAL SUPPORT REPRESENTATIVE. IF THE PRESSURE DISPLAYED ON THE SCREEN IS: GREATER THAN THE PRESSURE ON THE COLUMN INSPECTION REPORT + 4 MPA, THEN REPLACE THE FILTER. LESS THAN THE PRESSURE ON THE COLUMN INSPECTION REPORT, THEN PROCEED WITH PRIMING THE COLUMN. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN OBSTRUCTION IN THE TUBING FROM THE I6 PORT ON THE INJECTOR VALVE, TO THE BOTTOM OF THE PRE-FILTER ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE "100 PRESSURE HIGH" ERROR ON THEIR G8 ANALYZER. THE COLUMN COUNT WAS REPORTED TO BE 1500 INJECTIONS. TECHNICAL SUPPORT (TS) FOUND THAT WITH THE PRE-FILTER COMPLETELY REMOVED THE PRESSURE REMAINED GREATER THAN 7.0 MEGAPASCALS (MPA) WHICH INDICATED THERE WAS AN OBSTRUCTION BEFORE THE FILTER HOUSING. 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
    1032218 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1