BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7435119 · Received April 16, 2018

    Report

    Report Number
    3005529799-2015-00009
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Report Date
    February 3, 2021
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING REFILED PER FDA REQUEST TO INDICATE INITIAL REPORT TYPE. THIS REPORT IS AN "INITIAL" TO UF/IMPORTER REPORT #: 3005529799-2015-00009. CONTACT OFFICE: (B)(4). MANUFACTURER NAME/ADDRESS: (B)(4). DATE RECEIVED BY MANUFACTURER: 20-JUL-2015. 510K: K071132. ADVERSE EVENT: FOLLOW-UP # 1. TYPE OF EVENT: MALFUNCTION FOLLOW UP: CORRECTION, ADDITIONAL INFORMATION. ADVERSE EVENT CODES: (B)(4). DEVICE USAGE: REUSE. ADDITIONAL INFORMATION: THE MOST PROBABLE CAUSE OF THE ABNORMAL PEAKS IS RELATED TO THE EXTENDED COLUMN LIFE BEYOND 2500 INJECTIONS. REVIEW OF THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL INFORMS THE USER OF THE FOLLOWING: COLUMNS ARE WARRANTED FOR 2500 INJECTIONS. AFTER COLUMN REPLACEMENT, USE THE COLUMN RESET KEY TO RESET THE COLUMN COUNT. FLAG 06 MAY BE PROGRAMMED TO ALERT THE OPERATOR AFTER 2500 INJECTIONS ARE PERFORMED WITH A SPECIFIC COLUMN. WHEN THE FLAG FOR NUMBER OF INJECTIONS IS PROGRAMMED, EVERY SPECIMEN THAT EXCEEDS THE LIMIT WILL BE PRINTED WITH THE FLAG. 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 CAPA(B)(4).

    Description of Event or Problem · 1

    ON 20JUL-2015, TOSOH BIOSCIENCE, INC. WAS NOTIFIED OF ERRONEOUS PATIENT HBA1C RESULTS THAT WERE REPORTED ON 25-JUN-2015. THE TESTING WAS DONE ON A TOSOH HPLC G8 ANALYZER, AND ALL QUALITY CONTROLS WERE WITHIN ACCEPTABLE TARGET RANGES. CHROMATOGRAMS WERE REVIEWED AFTER THE RESULTS WERE REPORTED AND IT WAS DISCOVERED THAT THE CHROMATOGRAM PEAKS LOOKED ABNORMAL AND TEST RESULTS SHOULD NOT HAVE BEEN REPORTED. THE COLUMN COUNT AT THE TIME OF THIS EVENT WAS 3800, AND REQUIRED REPLACEMENT. FOLLOWING REPLACEMENT OF THE COLUMN, CALIBRATION WAS PERFORMED AND QUALITY CONTROLS RUN. QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE (LEVEL 1 RESULT: 6.3, ACCEPTABLE RANGE: 5.66 - 6.86; LEVEL 2 RESULT: 9.4, ACCEPTABLE RANGE: 8.37 - 9.94), AND THE CHROMATOGRAM PEAKS LOOKED NORMAL. OF THE 200 PATIENT RESULTS REVIEWED WITH ABNORMAL LOOKING CHROMATOGRAMS, APPROXIMATELY 43 SPECIMENS IN THE RANGE OF 7.0- TO 7.9 WERE REPEATED FOLLOWING INSTALLATION OF THE NEW COLUMN. THE REPEATED SPECIMEN RESULTS WERE LOWER, AND CORRECTED PATIENT RESULTS WERE REPORTED TO THE ORDERING PHYSICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278036 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown QUALITY CONTROL MAS 1606