BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7435145 · Received April 16, 2018

    Report

    Report Number
    8031673-2018-04985
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    September 2, 2015
    Report Date
    April 16, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE TO UTILIZE SUGGESTED CALIBRATION LOTS AND MONITORING OF QC RESULTS.

    Description of Event or Problem · 0

    ON (B)(6) 2015, THE CUSTOMER CALLED TO REPORT A HIGH BIAS ON HER CAP PRECISION TEST (PT). THE CUSTOMER STATED THEY WOULD FAX THE CAP DATA, ORIGINAL PRINTOUTS AND QUALITY CONTROL (QC) VALUES. ON (B)(6) 2015, TECHNICAL SUPPORT (TS) FOLLOWED UP WITH THE CUSTOMER. ANALYSIS OF THE DATA REVEALED THAT THE CUSTOMER REPORTED REFERENCE VALUES AND COEFFICIENT VARIATION (CVS) EXHIBITED LARGE BIAS AND/OR LARGE CVS. ALL THE CUSTOMER'S RESULTS WERE FOUND TO BE UNACCEPTABLE. WHEN ASKED IF MONTHLY MAINTENANCE CHECKS WERE PERFORMED THE CUSTOMER RESPONDED SHE DID NOT KNOW. ADDITIONAL QUESTIONS WERE ASKED REGARDING SAMPLE VOLUME (20,000/YEAR) FREQUENCY OF PERIODIC MAINTENANCE (PM). THE CUSTOMER WAS UNABLE TO ADDRESS TO THE QUESTIONS AT THE TIME BUT STATED THAT THEY FOLLOW UP WHEN THEY HAD THE INFORMATION. ON (B)(6) 2015, AFTER MULTIPLE ATTEMPTS, TS RECONNECT WITH THE CUSTOMER WHERE SHE PROVIDED THE REQUESTED INFORMATION. TS ALSO SENT THE CUSTOMER NOTIFICATIONS REGARDING NEW LOTS FOR CALIBRATORS, COLUMN CHANGES, AND MONTHLY MONITORING PROCEDURE. TS ALSO SENT CALIBRATOR LOT ZS4002 TO LAB FOR USE. THE CUSTOMER MADE ARRANGEMENTS FOR AN ALTERNATIVE PROFESSIONAL TEST SURVEY. NO FURTHER ACTION WAS REQUIRED BY TECHNICAL SUPPORT. TS ADDRESS THE REPORTED EVENT, WHICH RESULTED IN CAP SURVEY BIAS. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT SURVEY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277270 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1