BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLC-723 G8

    MDR report key: 14197801 · Received April 25, 2022

    Report

    Report Number
    3004529019-2022-00085
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 26, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEERING (FSE) WAS AT THE CUSTOMER'S SITE TO ADDRESS REPORTED EVENT. FSE WAS NOT ABLE TO CONFIRM OR REPRODUCED THE COMPLAINT. FSE FOUND THE SAMPLE LOOP CONTAMINATED AND REPLACED IT, CALIBRATED THE ANALYZER AND SUCCESSFULLY RAN PRECISION ON A PATIENT SAMPLE WITHOUT ANY ERRORS AND WITHIN ACCEPTABLE RANGE. FSE SUCCESSFULLY VALIDATED THE ANALYZER BY PERFORMED QC RUN WITHOUT ERROR AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO CONTAMINATION OF SAMPLE LOOP.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING HIGHER THAN EXPECTED HBA1C RESULTS ON THE G8 ANALYZER. THE CUSTOMER REPORTED ALL QUALITY CONTROL WAS IN RANGE AND THE G8 REPORTED A PATIENT'S RESULT WAS 0.75-1.0% HIGHER THAN EXPECTED WHEN COMPARED TO REFERENCE LAB RESULTS. THE PATIENT'S PHYSICIAN REQUESTED THAT THE PERFORMANCE OF THE G8 ANALYZER CHECKED SINCE THIS WAS A SECOND OCCURRENCE WITHIN A MONTH. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGHER PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494367 HLC-723 G8 HEMOGLOBIN A1C TEST SYSTEM PDJ TOSOH HI-TEC, INC. HLC-723 G8 N/A 04560189282919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown