BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 6219606 · Received January 3, 2017

    Report

    Report Number
    3005529799-2016-00020
    Event Type
    Injury
    Date Received
    January 3, 2017
    Date of Event
    December 9, 2016
    Report Date
    April 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CORRECTIONS WERE RECORDED IN THE PRESENT SUPPLEMENTAL MDR IN THE NOTED SECTIONS: UNK. UNK. UNK. UNK. UNK. UNK. PRODUCT PROBLEM. BLANK FIELD. N/A. N/A. SUSPECT PRODUCT(S) - NO. TOSOH HLC-723G8 ANALYZER G8. TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING. 3-8-2 SHIBA / MINATO-KU. TOKYO 1058623 JAPAN. UDI - (B)(4). HEALTH PROFESSIONAL. NO. YES. HEALTH PROFESSIONAL. DORIA ESQUIVEL. 6000 SHORELINE COURT SUITE 101. SOUTH SAN FRANCISCO CA 94080 USA. (650)636-8123. [email protected]. 12-19-2016. FOLLOW-UP #1. OUTPATIENT DIAGNOSTIC FACILITY. TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING. 3-8-2 SHIBA / MINATO-KU. TOKYO 1058623 JAPAN. DORIA ESQUIVEL. 6000 SHORELINE COURT SUITE 101. SOUTH SAN FRANCISCO CA 94080 USA. (650)636-8123. [email protected]. TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING. 3-8-2 SHIBA / MINATO-KU. TOKYO 1058623 JAPAN. HEALTH PROFESSIONAL. 12/19/2016 PMA/510K: K071132. MALFUNCTION. CORRECTION / ADDITIONAL INFORMATION. NO / RESOLVED OVER THE PHONE / NOT RETURNED TO MANUFACTURER. 04/01/2011. NO. PATIENT CODE(S): 2692. DEVICE CODE(S): 2456. METHOD CODE(S): 3263. RESULT CODE(S): 213. CONCLUSION CODE(S): 71. REUSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A COMBINATION OF A SPECIMEN WITH A HEMOGLOBIN VARIANT THAT CAUSED INTERFERENCE AND MADE THE RESULTS NON-REPORTABLE AND THE OPERATOR NEEDED ADDITIONAL TRAINING.. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER (B)(4). SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON 12/19/2016: TOSOH BIOSCIENCE NOTIFIED THAT AN INCORRECT HBA1C OF 4.94% HAD BEEN REPORTED ON (B)(6) 2016. THE SPECIMEN REPEATED WITH A RESULT OF 5.01%. THE SPECIMEN WAS SENT OUT AND USING A DIFFERENT METHODOLOGY THE HBA1C RESULTS WAS 9.1%. REVIEW OF THE CHROMATOGRAMS FOR THE TESTING DONE ON (B)(6) 2016 INDICATED "CHECK PEAKS" FLAGS WITH VARIANT RETENTION TIMES LISTED AS PRIOR TO THE A0 WHICH MADE THE RESULT NON-REPORTABLE BUT RESULT WAS REPORTED. ROOT CAUSE: SPECIMEN VARIANT INTERFERENCE THAT ELUTED BEFORE THE A0 PEAK WHICH MADE THE RESULT NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3003 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other