BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7037503 · Received November 16, 2017

    Report

    Report Number
    8031673-2017-00106
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 17, 2017
    Report Date
    February 12, 2017
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER REGARDING THE RESULT IN QUESTION WERE MADE WITHOUT SUCCESS. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE G8, SERIAL NUMBER (B)(4), FROM 17-SEP-2016 THROUGH 17-OCT-2017. THERE WERE NO OTHER SIMILAR EVENTS IDENTIFIED DURING THE SEARCHED PERIOD. THE ST AIA-PACK HBA1C ASSAY SPECIFICATIONS UNDER LIMITATIONS OF THE PROCEDURE ON PAGE 8 STATES THE FOLLOWING: FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). SAMPLES FROM PATIENTS TAKING MEDICINES AND / OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE CUSTOMER REGARDING THE SUBJECT SAMPLE IN QUESTION. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: CONCLUSION IS NOT YET AVAILABLE; INVESTIGATION IS IN-PROCESS. ADDITIONAL INFORMATION IS BEING REQUESTED WITH THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: CONCLUSION IS NOT YET AVAILABLE; INVESTIGATION IS IN-PROCESS. ADDITIONAL INFORMATION IS BEING REQUESTED WITH THE CUSTOMER. CORRECTED DATA: REPORT SOURCE: "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER CALLED CONCERNED ABOUT A LOW HEMOGLOBIN AIC (HBA1) RESULT OF 4.1% (REFERENCE RANGE 3.8 - 6.0%) ON A PATIENT SAMPLE WITH THE G8 INSTRUMENT. THE PATIENT'S GLUCOSE LEVEL WAS REPORTED AT 95 MG/DL. THE RETENTION TIME ON HBA1C WAS 0.58 MINUTES, WHICH WAS WITHIN RANGE (ACCEPTABLE RANGE OF 0.57 - 0.61 MINUTES). THE CUSTOMER REPORTED THAT QUALITY CONTROLS WERE ALSO WITHIN RANGE. THIS PATIENT HAD BEEN PREVIOUSLY TESTED IN (B)(6) 2017 WITH AN HBA1C RESULT OF 4.0%. THE CUSTOMER REPORTED THAT THE INITIAL METHOD WAS DONE WITH A G7. THE PATIENT WAS ON IRON AND MULTIVITAMIN LOTRISONE CREAM. THE TECHNICAL SUPPORT SPECIALIST SUGGESTED TO THE CUSTOMER TO SEND THE SUBJECT SAMPLE OUT FOR CONFIRMATION TO A REFERENCE LAB. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817845 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1