BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000 ST

    MDR report key: 21684414 · Received March 24, 2025

    Report

    Report Number
    3004529019-2025-00708
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 25, 2025
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284616
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE CUSTOMER VIA PHONE REGARDING THE REPORTED EVENT AND CONFIRMED THE ISSUE BY REVIEWING THE CUSTOMER PRINTOUTS THAT WERE SENT. ALL RESULTS WERE IN RANGE, BUT WERE TRENDING LOW. A TECHNICAL SUPPORT SPECIALIST (TSS) SENT A NEW LOT OF TEST CUPS AND THE FSE HAD A NEW LOT OF CALIBRATORS SENT TO THE CUSTOMER. MULTI ANALYTE CONTROL (MAC) CONTROLS IMPROVED WITH THE NEW LOT CALIBRATION, BUT BIO-RAD QUALITY CONTROL (QC) WAS MOSTLY UNCHANGED AND STILL TRENDING LOW, WITHIN RANGE. ALL QC WAS IN RANGE, BUT WAS TRENDING BELOW MEAN VALUES FOR VITAMIN B12 (B12). THE CUSTOMER AGREED TO MONITOR UNTIL THE LOTS ARE CHANGE TO THE NEW LOTS. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) THROUGH THE AWARE DATE. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR VITAMIN B12 LOT NUMBER E811866, BIO-RAD LOT NUMBERS 1003901, 1003902 AND 1003903 THROUGH THE AWARE DATE. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE ST VITAMIN B12, ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE: FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G. SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). USING AIA-PACK B12, THE HIGHEST CONCENTRATION OF VITAMIN B12 MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 2000 PG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 50 PG/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 2100 PG/ML, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 2000 PG/ML. ALTHOUGH HEMOLYSIS HAS AN INSIGNIFICANT EFFECT ON THE ASSAY, HEMOLYZED SAMPLES MAY INDICATE MISTREATMENT OF A SPECIMEN PRIOR TO ASSAY AND RESULTS SHOULD BE INTERPRETED WITH CAUTION. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SAMPLES FROM PATIENTS WHO HAD AN INJECTION OF FLUORESCEIN, WHICH IS USED IN FLUORESCEIN FUNDUS ANGIOGRAPHY, MAY CAUSE FALSELY ELEVATED RESULTS. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. SPECIMENS FROM PATIENTS TAKING MEDICINES AND/OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. THE MOST PROBABLE CAUSE OF THE REPORTED DISCREPANT RESULTS WAS UNABLE TO BE ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED "VITAMIN B12 (B12) QUALITY CONTROL (QC) SHIFTING LOW AND DISCREPANT RESULTS THAT WERE REPORTED OUT" ON THE AIA-2000 ANALYZER. THE CUSTOMER RECALIBRATED THE PREVIOUS DAY AND MADE NEW SUBSTRATE. THE CUSTOMER WAS UNABLE TO CONFIRM IF THE BLEACH WAS OLD AND COULD NOT CONFIRM HOW LONG THE TEST CUPS SIT OUT AT ROOM TEMPERATURE BEFORE RUNNING. THE PHYSICIAN COMPLAINED THAT THE RESULTS WERE LOWER THAN THEY ACTUALLY ARE AND WAS REFERRING TO THE PATIENT HISTORY TO MAKE THAT DETERMINATION. THE RESULTS WERE NOT SENT OUT TO CONFIRM AND THE CUSTOMER DID NOT PROVIDE EXAMPLES/VALUES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER INVESTIGATE THE POTENTIAL DISCREPANT RESULTS FOR VITAMIN B12. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695173 AIA-2000 ST FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 ST N/A 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown