BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7371719 · Received March 26, 2018

    Report

    Report Number
    8031673-2018-03251
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    October 30, 2015
    Report Date
    March 26, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(4) 2015, AN TSS CONDUCTED FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. TSS PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND FOUND DISCREPANT PATIENT RESULTS. THE CUSTOMER'S PRIOR LOT OF QC WAS IN RANGE, A NEW LOT WAS STARTED JUST LAST WEEK. THE LOTS DID NOT RUN IN PARALLEL, BUT THE CUSTOMER JUST SWITCHED OVER TO THE NEW LOT AND L2 HAS BEEN LOW EVER SINCE. THE CUSTOMER MADE NEW QC. THE CUSTOMER CALLED BACK AND STATED THAT THE RANGES IN HER COMPUTER SYSTEM WERE NOT UPDATED FOR THE NEW LOT AND THAT ALL HER CONTROLS ARE NOW IN RANGE. THE AIA-360 ANALYZER IS FUNCTIONING AS INTENDED WITH ALL ISSUES CLEARED. NO FURTHER ACTION BY TSS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO INCORRECT RANGES. TOSOH BIOSCIENCE, INC. IS SUBMITTNG 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 · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED LOW L2 QC ON PTH USING QC LOT 89 WITH THEIR AIA-360 ANALYZER. THE CUSTOMER IS UNABLE TO RUN PTH PATIENT SAMPLES. A TECHNICAL SUPPORT SPECIALIST ADDRESSED THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING PTH 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
    211970 AIA-360 AIA-360 LCP TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1