BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 8240562 · Received January 11, 2019

    Report

    Report Number
    8031673-2018-05425
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K131580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM 21NOV2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE HEMAGLOBIN A1C AIA-PACK PACKAGE INSERTS STATE THE FOLLOWING: SPECIMEN COLLECTION AND HANDLING. EDTA WHOLE BLOOD IS REQUIRED FOR THE ASSAY. HEPARINIZED OR CITRATED WHOLE BLOOD SHOULD NOT BE USED. WHOLE BLOOD SAMPLES SHOULD BE PRETREATED WITHIN 24 HOURS AT 30 °C. IF THE PRETREATMENT CANNOT BE DONE WITHIN 24 HOURS, WHOLE BLOOD SAMPLES SHOULD BE STORED AT 10 °C FOR UP TO 7 DAYS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 7 DAYS, WHOLE BLOOD SAMPLES SHOULD BE STORED FROZEN AT -20 °C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. PRIOR TO THE ASSAY, SLOWLY BRING FROZEN SAMPLES TO 30 °C AND MIX GENTLY. WHOLE BLOOD SAMPLES REQUIRE MANUAL PRETREATMENT PRIOR TO THE ASSAY USING ST AIA-PACK HBA1C PRETREATMENT SOLUTION. WHOLE BLOOD SAMPLES ARE DILUTED BY 21 FOLDS WITH THE PRETREATMENT SOLUTION AND THE DILUTED SAMPLES ARE INCUBATED AT 40 +/- 2°C FOR 20 +/- 3 MINUTES. THE ANALYSIS OF PRETREATED SAMPLES SHOULD BE DONE WITHIN 2 HOURS AFTER COMPLETION OF THE PRETREATMENT PROCESS. IF THE ANALYSIS CANNOT BE DONE WITHIN 2 HOURS, THE PRETREATED SAMPLES SHOULD BE STORED AT 10 °C FOR UP TO 24 HOURS. PRETREATED SAMPLES SHOULD NOT BE STORED AS FROZEN. VOLUME OF PRETREATED SAMPLE REQUIRED FOR ANALYSIS OF HBA1C IS 10 MICROLITERS. LIMITATIONS OF PROCEDURE: 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.). USING ST AIA-PACK HBA1C, THE HIGHEST CONCENTRATION OF HBA1C MEASURABLE IS 14.0%, AND THE LOWEST MEASURABLE CONCENTRATION IS 3.0%. IN THE CASE OF SEVERE ANEMIA SPECIMENS HAVING LESS THAN 7.0 G/DL TOTAL HEMOGLOBIN CONCENTRATION, ST AIA-PACK HBA1C MAY GIVE LOWER RESULT. SUCH SEVERE ANEMIA SPECIMEN SHOULD BE ASSAYED BY A DIFFERENT ASSAY PRINCIPLE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SAMPLES CONTAINING FIBRIN MAY EXHIBIT EITHER FALSELY ELEVATED OR FALSELY DECREASED RESULTS. FIBRIN MUST BE ELIMINATED FROM THE SAMPLE BEFORE ASSAY BEGINS. SAMPLES FROM PATIENTS TAKING MEDICINES AND / OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. SAMPLES FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF SHEEP POLYCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-SHEEP ANTIBODY. SUCH SAMPLES MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR ST AIA-PACK HBA1C. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE & STABILITY AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE SURVEY SAMPLE REPEATED WITHIN THE ACCEPTABLE RANGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DURING THEIR (B)(6) HBA1C PROFICIENCY TESTING SURVEY SAMPLES GH5-C SAMPLE GH-11 FAILED DID NOT PASS ON THEIR G8 ANALYZER. THE CUSTOMER RECEIVED AN INITIAL RESULT OF 8.5% (RANGE 8.8-10.0%), AND 9.4% AFTER REPEATING. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY TECHNICAL SUPPORT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34242 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1