BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

    MDR report key: 14094818 · Received April 13, 2022

    Report

    Report Number
    3004529019-2022-00080
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 13, 2022
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    PDJ
    UDI-DI
    04560189282919
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED IN RESPONSE TO A COMPLAINT OF SA1C DISCREPANT PATIENT RESULTS. AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER (FSE) RESOLVED THE REPORTED ISSUE BY REPLACING UPTAKE AND PURGE VALVE. DECREASED FLOW RATE FROM 1.17 TO 1.05 AND RAN SEVERAL RESULTS WITH RETENTION TIMES WITHIN MANUFACTURER SPECIFICATIONS. THE INVESTIGATION REVEALED A MECHANICAL FAILURE DUE TO A COMPONENT FAILURE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 14 FEB 2021 THROUGH AWARE DATE 14 MAR 2022. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A PATIENT SAMPLE WAS RAN ON THE G8 ANALYZER AND THE RESULT WAS QUESTIONED BY THE DOCTOR. THE SA1C DISCREPANT PATIENT RESULTS HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425984 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 HEMOGLOBIN A1C TEST SYSTEM PDJ TOSOH HI-TEC, INC. HLC-723 G8 N/A 04560189282919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown