AIA-2000
Report
- Report Number
- 3004529019-2025-00712
- Event Type
- Malfunction
- Date Received
- April 7, 2025
- Date of Event
- March 10, 2025
- Report Date
- April 7, 2025
- Manufacturer
- TOSOH HI-TEC, INC.
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE ST AIA-PACK FT3 ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED. THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: AFTER CALIBRATION, TWO LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. THE TWO LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. FREE TRIIODOTHYRONINE REV-0025286-1119 LBL-00073 [1] 8. 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 ST AIA-PACK FT3, THE HIGHEST CONCENTRATION OF FREE TRIIODOTHYRONINE MEASURABLE IS APPROXIMATELY 25.0 PG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.5 PG/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 25.0 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, 25 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. HEPARIN MAY CAUSE IN VIVO EFFECTS IN FREE T3 ASSAYS. BLOOD COLLECTION FOR FREE T3 ASSAYS SHOULD NOT BE PERFORMED CONCURRENT WITH ADMINISTRATION OF HEPARIN THERAPY. 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. SPECIMENS FROM PATIENTS UNDER TREATMENT WITH DICLOFENAC SODIUM AND MEFENAMIC ACID MAY DEMONSTRATE FALSELY ELEVATED RESULTS. PATIENTS WITH ANTI-T3 ANTIBODY MAY ALSO SHOW FALSE RESULTS. SAMPLES FROM PATIENTS WHO HAD AN INJECTION OF FLUORESCEIN, WHICH IS USED IN FLUORESCEIN FUNDUS ANGIOGRAPHY, MAY CAUSE FALSELY ELEVATED RESULTS. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE AND STABILITY, AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. THE ST AIA-PACK FT4 ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: AFTER CALIBRATION, TWO LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE.THE TWO LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. 8 REV-0025268-1119, LBL-00066 [1], ST AIA-PACK FT4. 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 ST AIA-PACK FT4, THE HIGHEST CONCENTRATION OF FREE THYROXINE MEASURABLE IS APPROXIMATELY 8.0 NG/DL, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.10 NG/DL (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 9.0 NG/DL, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 8.0 NG/DL. 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. CIRCULATING AUTOANTIBODIES TO T4 MAY INTERFERE WITH THE FREE THYROXINE MEASUREMENTS. HORMONE-BINDING INHIBITORS MAY INTERFERE WITH THE FREE T4 ASSAY. HEPARIN MAY CAUSE IN VIVO EFFECTS IN FREE T4 ASSAYS. BLOOD COLLECTION FOR FREE T4 ASSAYS SHOULD NOT BE PERFORMED CONCURRENT WITH ADMINISTRATION OF HEPARIN THERAPY. 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. DRUGS WHICH AFFECT THE BINDING OF T4 TO THE THYROID HORMONE CARRIER PROTEINS OR AFFECT THE METABOLISM OF T4 TO T3 MAY COMPLICATE THE INTERPRETATION OF FREE THYROXINE RESULTS. IN PATIENTS WITH SEVERE NON-THYROIDAL ILLNESS (NTI) IN WHOM THE FREE T4 YIELDS RESULTS INDICATING HYPOTHYROIDISM, IT IS SUGGESTED THAT THE AIA-PACK TSH 3RD-GEN OR ST AIA-PACK TSH ASSAY BE RUN TO CONFIRM THIS DIAGNOSIS. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE AND STABILITY, AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. THE ST AIA-PACK IPTH ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: AFTER CALIBRATION, TWO LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. THE TWO LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. 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 ST AIA-PACK INTACT PTH, THE HIGHEST CONCENTRATION OF INTACT PARATHYROID HORMONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 2,000 PG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 1.0 PG/ML (ASSAY SENSITIVITY). THE EXACT LINEARITY OF THE ST AIA-PACK INTACT PTH DEPENDS ON THE PARTICULAR LOT OF CALIBRATOR IN USE. ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 2,200 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. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF GOAT POLYCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-GOAT ANTIBODIES. SUCH SPECIMENS MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR INTACT PARATHYROID HORMONE. 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. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE AND STABILITY, AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. THE MOST PROBABLE CAUSE OF THE REPORTED FAILURE FOR FT3 AND IPTH COULD NOT BE ESTABLISHED, NO FINDINGS AVAILABLE. THE MOST PROBABLE CAUSE OF THE REPORTED FAILURE FOR FT4 WAS TRACED TO BIOLOGICAL CONTAMINATION, CAUSE TRACED TO MAINTENANCE.
A CUSTOMER REPORTED FAILING 2025 CHEMISTRY CORE 1ST EVENT AMERICAN PROFICIENCY INSTITUTE (API) TESTING FOR FREE TRIIODOTHYRONINE (FT3), NON-PROTEIN-BOUND (FREE) THYROXINE (FT4), AND INTACT PARATHYROID HORMONE (IPTH) ON THE AIA-2000 ANALYZER. THE CUSTOMER STATED THE FAILURE FOR FT3 WAS ONLY ON CH-01 AND CH-04 AND IPTH FAILURE WAS ONLY ON SAMPLES IAS-02 AND IAS-04. THE CUSTOMER DID NOT TAKE ANY FURTHER ACTION FOR THESE FAILURES AND WAS NOTIFYING TOSOH FOR DOCUMENTATION PURPOSES. THE CUSTOMER'S MAIN CONCERN WAS THE FT4, WHERE ALL FIVE (5) SAMPLES FAILED. THE CUSTOMER USED FT4 TEST CUP LOT E917589, CALIBRATOR LOT E734657, AND BIO-RAD LOT 85390. THE CUSTOMER STATED THEY PERFORMED A DECONTAMINATION IN (B)(6) 2024. TECHNICAL SUPPORT SPECIALIST (TSS) SUGGESTED THE CUSTOMER PERFORM A DECONTAMINATION AND RECALIBRATE. THE CUSTOMER RERAN THE API SAMPLES FOR FT4 AFTER DECONTAMINATION, AND ALL RESULTS WERE THEN WITHIN ACCEPTABLE RANGE, THESE RESULTS WERE NOT SHARED WITH TSS. TOSOH QUALITY LAB PASSED ALL FIVE PROFICIENCY SAMPLES FOR FT3, FT4, AND IPTH. NO FURTHER ACTION REQUIRED BY TECHNICAL SUPPORT AT THIS TIME. THE ANALYZER IS OPERATING AS EXPECTED. 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 |
|---|---|---|---|---|---|---|---|
| 646746 | AIA-2000 | FLUOROMETER, FOR CLINICAL USE | KHO | TOSOH HI-TEC, INC. | AIA-2000 ST | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |