BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8031673-2018-02807

    MDR report key: 7336977 · Received March 13, 2018

    Report

    Report Number
    8031673-2018-02807
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    January 12, 2017
    Report Date
    March 13, 2018
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (B)(4). TECHNICAL SUPPORT VERIFIED ALL ASPECTS OF PROPER TECHNIQUE AND SAMPLE HANDLING. THEY WERE UNABLE TO DUPLICATE THE ISSUE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED THAT PATIENT HGA1C DIABETES RESULTS WERE DECREASING AS THE SAMPLE AGES WITH THEIR AIA-360 ANALYZER. THE CUSTOMER REPORTED THAT TWO PATIENT SAMPLES WERE OBTAINED AND RAN ON (B)(6) 2017 AND REPEATED ON (B)(6) 2017. WHAT THEY FOUND WAS THAT THE RESULTS DECREASED BY 0.5 AND 1.2 POINTS RESPECTIVELY ON (B)(6) 2017 USING THE SAME CONTROL MATERIAL THAT WAS IN RANGE. THE ACCOUNT ALSO REPEATED THE SECOND OF THE PATIENT SAMPLES ON (B)(6) 2017 WHICH RESULTED IN A FURTHER DECREASE IN RESULTS BY 0.4 POINTS. DURING THIS RUN, THE SAME PRECISION TEST LOT WAS USED FOR BOTH TEST RUNS EXCEPT WITH A DIFFERENT BOTTLE. HOWEVER, THE PRECISION TEST FROM (B)(6) 2017 WAS 2-3 DAYS OLD AFTER OPENING. TECHNICAL SUPPORT DISCUSSED PROPER SETUP TECHNIQUE WITH THE ACCOUNT AND THERE WERE NO ISSUES FOUND. ALL PRETREATED AND NON-PRETREATED SAMPLES WERE RUN PROPERLY AND NO QUALITY CONTROL ISSUES WERE IDENTIFIED. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT PATIENT RESULTS. THE ACCOUNT PERFORMED AN INHOUSE STUDY RUNNING A HIGH HGBA1C PATIENT SAMPLE AND A LOW HGBA1C SAMPLE EACH DAY FOR 7 DAYS. BESIDES A DIFFERENT OPERATOR RUNNING THE SAMPLE AND A CHANGE IN SUBSTRATE ON DAY 3, IT APPEARED THAT THE HIGH AND LOW PATIENT SAMPLES HAD NORMAL VARIATION FROM DAY TO DAY.

    Patients

    Seq Age Sex Outcome Treatment
    1