BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7717046 · Received July 24, 2018

    Report

    Report Number
    8031673-2018-00646
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 24, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE G8 SERIAL NUMBER (B)(4), FROM 26MAY2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES THE FOLLOWING: ABNORMAL CHROMATOGRAMS: ALTHOUGH THE PERCENTAGE OF EACH HEMOGLOBIN COMPONENT MAY VARY SLIGHTLY FROM PATIENT TO PATIENT, MOST WHOLE BLOOD SAMPLES WILL CONTAIN SIX FRACTIONS: A1A, A1B, F, LA1C+, SA1C, AND A0. A NORMAL CHROMATOGRAM IS SHOWN BELOW IN FIGURE 6-2. CHROMATOGRAMS FROM PATIENTS WITH HEMOGLOBIN VARIANTS OR UNKNOWN PEAKS NOT RECOGNIZED BY THE ANALYZER ARE OCCASIONALLY SEEN DURING ROUTINE TESTING. THESE PATTERNS MAY INDICATE INTERFERENCES OR PROBLEMS WITH THE ASSAY. THEREFORE, IT IS IMPORTANT TO USE CAUTION WHEN TROUBLESHOOTING. REVIEW ALL CHROMATOGRAMS TO DETERMINE WHETHER THE RESULTS ARE VALID. IN MOST CASES, RESULTS FOR THE SA1C% ARE REPORTABLE. IN SOME CASES, THE SA1C% MAY BE INVALID DEPENDING ON THE HEMOGLOBINOPATHY PRESENT, THE FLOW RATE, AND THE CONDITION OF THE COLUMN AND REAGENT SYSTEM. MATHEMATICAL ALGORITHMS USED IN THE SOFTWARE EXCLUDE VARIANT PEAKS ELUTING AFTER THE A0 PEAK WHEN CALCULATING THE TOTAL AREA. THE SA1C% IS USUALLY NOT AFFECTED IN SUCH SITUATIONS, ALTHOUGH CHROMATOGRAMS SHOULD BE CAREFULLY REVIEWED. HBS, HBD AND HBC ELUTE AFTER THE A0 PEAK. THE SA1C% IS GENERALLY REPORTABLE ON THE G8 WHEN THESE HEMOGLOBINS ARE PRESENT IN THE HETEROZYGOUS STATE WITH HBA. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 HAS KNOWN HEMOGLOBIN E (HBE) INTERFERENCE. WHEN A SAMPLE IS SUSPECTED TO CONTAIN HBE A FLAG WILL BE DISPLAYED. THE HBA1C RESULT WILL NOT BE REPORTED FROM THE ANALYZER. FLAG CODE 43 CAN BE USED TO DETECT THE PRESENCE OF A P-HV3 PEAK WHERE THE HBE VARIANT TYPICALLY ELUTES. (SEE CHAPTER 4, SECTION 4.18 "FLAG PARAMETER SETTING" FOR A DESCRIPTION OF FLAG SETTINGS). GLYCEMIC MONITORING FOR PATIENTS DISPLAYING ANY HOMOZYGOUS HEMOGLOBIN OTHER THAN HBAA SUCH AS HBSS, HBCC OR THE DOUBLE HETEROZYGOUS HBSC, CANNOT BE PERFORMED USING SA1C BECAUSE THERE IS NO HBA PRESENT. ALTERNATIVE TESTING IS MANDATORY FOR THESE TYPES OF PATIENTS. THE PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO POSSIBLE HEMOGLOBINOPATHY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A STABLE HEMOGLOBIN A1C (SA1C) RESULT OF 53.9 ON A PATIENT RESULT WITH NO FLAGS OR ERROR MESSAGES ON THE G8 INSTRUMENT. THE CUSTOMER REPEATED THE RUN AND STILL GOT THE SAME RESULT. THE CUSTOMER REPORTED THAT ALL PATIENT SAMPLES THAT WERE RUN BEFORE AND AFTER WERE NORMAL. THE CUSTOMER SENT CHROMATOGRAM TO TECHNICAL SUPPORT SPECIALIST (TSS) AND TSS REVIEWED RESULT AND EXPLAINED TO THE CUSTOMER THAT THE PATIENT RESULT WAS GREATER THAN 16.9 (RANGE 4.0 - 16.9%) WHICH IS THE UPPER LEVEL OF MEASUREMENT FOR SA1C ON THE G8 ANALYZER AND MAY INDICATE THE PRESENCE OF A HEMOGLOBINOPATHY. CUSTOMER WAS ALSO INFORMED RESULT WAS NOT REPORTABLE BECAUSE IT WAS ABOVE THE REPORTABLE RANGE FOR THE G8. TSS ADVISED CUSTOMER TO SEND OUT SAMPLE FOR ALTERNATE METHOD TESTING. TSS FOLLOWED UP WITH CUSTOMER AT A LATER DATE AND CUSTOMER INFORMED TSS THAT THE SAMPLES WERE NOT SENT OUT FOR ANALYSIS BY ALTERNATE METHOD. CUSTOMER INSTRUCTED PATIENT TO GO TO A DIFFERENT FACILITY TO HAVE HBA1C RUN. NO FURTHER ASSISTANT REQUESTED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557502 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1