BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7605798 · Received June 15, 2018

    Report

    Report Number
    8031673-2018-00541
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 25, 2018
    Report Date
    June 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. FSE FOLLOWED UP WITH THE CUSTOMER OVER THE PHONE TO ADDRESS THE REPORTED EVENT. FSE ASSISTED CUSTOMER WITH THE REINSTALLATION OF THE VERSION 5.23 SOFTWARE ALREADY LOCATED IN HER TOSOH PROVIDED TOOL BOX. NO FURTHER ISSUES WERE NOTED. 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)(4) FROM 25APR2017 THROUGH AWARE DATE 25MAY2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL VERSION 3.0, UNDER CHAPTER 7- DATA MANAGEMENT WAS REVIEWED. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 7- DATA MANAGEMENT STATES THE FOLLOWING: 7.1 DATA MANAGEMENT DETAILS THE ANALYZER'S SYSTEM PROGRAM AND ASSAY PARAMETERS ARE BACKED UP BY THE INTERNAL BATTERY. WHEN A SYSTEM PROGRAM VERSION HAS BEEN UPGRADED OR SOME PROBLEM HAS CORRUPTED THE SYSTEM PROGRAM, USE THE FOLLOWING PROCEDURE TO RELOAD THE PROGRAM AND OTHER DATA FROM THE SMART MEDIA SOCKET (REFER TO PAGES 183-187 FOR DETAILED EXPLANATION). THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO A POWER FAILURE RESULTING IN CORRUPTED SOFTWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A MAJOR POWER OUTAGE RESULTING IN CORRUPTED SOFTWARE WITH THEIR G8 ANALYZER. 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
    449918 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1