BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7

    MDR report key: 7380095 · Received March 28, 2018

    Report

    Report Number
    8031673-2018-04139
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    November 11, 2015
    Report Date
    March 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10.ADDITIONAL MANUFACTURER NARRATIVE: 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 2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3.DEVICE BY MANUFACTURER: ON 11-NOV-2015, A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT WHERE THE CUSTOMER INFORMED THAT THEY HAD FAILED API SURVEY. TSS SENT A NEW COLUMN AND CALIBRATORS FOR EVALUATION. CUSTOMER ADVISED NEW COLUMN AND CALIBRATORS RESOLVED THE UNACCEPTABLE PT RESULTS. NO FURTHER ACTION REQUIRED. THE PROBABLE CAUSE OF THE EVENT WAS LOT TO LOT VARIABILITY.

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED FAILED API SURVEY WITH THEIR G7 ANALYZER. CUSTOMER REPORTS FAILED API SURVEY ON THE G7. GLY-11 13.3 [9.7-14.7], GLY 12 - 7.9 [4.6-7.0], GLY 13 - 13.1 [7.3-11.1], GLY 14 - 8.3 [4.0-7.0], GLY 15 - 16.8 [9.5-14.4]. CALIBRATED WITH LOT ZS4002, 1.1129X + 0.6655. (B)(4), FC 36. REPORTS THAT QUALITY CONTROL (QC) MEAN FOR MAS DBCL 1702 IN SEPT WAS 6.2 AND 9.8. L1 QC MEAN FOR OCT WAS 6.4, L2 WAS STILL 9.8. TSS ASKED TO SEE QC API REPORT. ADVISED TO PERFORM THE MONTHLY MONITORING CHECK AND RECALIBRATE. MONTHLY MAINTENANCE CHECKS - CHECK DILUTION PROCESS - 6.3 /WASH; 6.1/DI. CHECK SAMPLING PROCESS - 6.1 WHOLE BLOOD; 6.3 MANUAL DILUTION. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222490 G7 G7 LCP TOSOH CORPORATION G7

    Patients

    Seq Age Sex Outcome Treatment
    1