AIA-900
Report
- Report Number
- 8031673-2019-00019
- Event Type
- Malfunction
- Date Received
- February 20, 2019
- Date of Event
- June 25, 2018
- Report Date
- February 20, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS CUSTOMER'S REPORTED ISSUE. FSE FOLLOWED UP WITH THE CUSTOMER OVER THE PHONE AND THE CUSTOMER INFORMED THE FSE THAT THEIR INSTRUMENT IS FUNCTIONING WITHOUT ERRORS AFTER REPLACING THE WASH AND DILUENT. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 INSTRUMENT 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 AWARE DATE. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 4 - INSTALLATION AND SECTION 5 - SYSTEM PREPARATIONS PROVIDES DETAILED INSTRUCTIONS ON HOW TO PREPARE AND INSTALL THE WASH, DILUENT AND SUBSTRATE. THE ST AIA-PACK IRI ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: PROCEDURE REAGENT PREPARATION 1A) SUBSTRATE SOLUTION BRING ALL REAGENTS TO ROOM TEMPERATURE (18° - 25° C) BEFORE PREPARING THE WORKING REAGENT. ADD THE ENTIRE CONTENTS OF THE SUBSTRATE RECONSTITUENT (100 ML) TO THE LYOPHILIZED SUBSTRATE AND MIX THOROUGHLY TO DISSOLVE THE SOLID MATERIAL. 1B)WASH SOLUTION ADD THE ENTIRE CONTENTS OF THE WASH CONCENTRATE (100 ML) TO APPROXIMATELY 2.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 2.5 L. 1C) DILUENT ADD THE ENTIRE CONTENTS OF THE DILUENT CONCENTRATE (100 ML) TO APPROXIMATELY 4.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 5.0 L. 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, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. · THE THREE 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. THE ST AIA-PACK VITAMIN D ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: 1. REAGENT PREPARATION A. SUBSTRATE SOLUTION BRING ALL REAGENTS TO 18-25°C BEFORE PREPARING THE WORKING REAGENT. ADD THE ENTIRE CONTENTS OF THE AIA-PACK SUBSTRATE RECONSTITUENT II (100 ML) TO THE AIA-PACK SUBSTRATE REAGENT II (LYOPHILIZED), AND MIX THOROUGHLY TO DISSOLVE THE SOLID MATERIAL. B. WASH SOLUTION ADD THE ENTIRE CONTENTS OF THE AIA-PACK WASH CONCENTRATE (100 ML) TO APPROXIMATELY 2.0 L OF CAP CLASS I WATER OR THE CLINICAL LABORATORY REAGENT WATER (FORMALLY NCCLS TYPE I) DEFINED BY CLSI C3-A4 GUIDELINE, MIX WELL, AND ADJUST THE FINAL VOLUME TO 2.5 L. C. DILUENT ADD THE ENTIRE CONTENTS OF THE AIA-PACK DILUENT CONCENTRATE (100 ML) TO APPROXIMATELY 4.0 L OF CAP CLASS I WATER OR THE CLINICAL LABORATORY REAGENT WATER (FORMALLY NCCLS TYPE I) DEFINED BY CLSI C3-A4 GUIDELINE, MIX WELL, AND ADJUST THE FINAL VOLUME TO 5.0 L. D. PRETREATMENT REAGENT USING A VOLUMETRIC PIPETTE, DISPENSE 5ML OF THE ST AIA-PACK VITAMIN D PRETREATMENT-1 INTO A BARCODED REAGENT VIAL FOR PRETREATMENT-1. THE ST AIA-PACK VITAMIN D PRETREATMENT-2 IS PROVIDED READY FOR USE. EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT CONTROL SAMPLES SHALL BE ASSAYED ACCORDING TO THE LOCAL, STATE AND FEDERAL REGULATIONS. 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, TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZER. 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 LOCAL, STATE AND FEDERAL REGULATIONS. THE ST AIA-PACK IPTH ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: PROCEDURE REAGENT PREPARATION 1A) SUBSTRATE SOLUTION BRING ALL REAGENTS TO 18° - 25° C BEFORE PREPARING THE WORKING REAGENT. ADD THE ENTIRE CONTENTS OF THE SUBSTRATE RECONSTITUENT (100 ML) TO THE LYOPHILIZED SUBSTRATE AND MIX THOROUGHLY TO DISSOLVE THE SOLID MATERIAL. 1B)WASH SOLUTION ADD THE ENTIRE CONTENTS OF THE WASH CONCENTRATE (100 ML) TO APPROXIMATELY 2.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 2.5 L. 1C) DILUENT ADD THE ENTIRE CONTENTS OF THE DILUENT CONCENTRATE (100 ML) TO APPROXIMATELY 4.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 5.0 L. 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. THE ST AIA-PACK PROG & E2 ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: PROCEDURE REAGENT PREPARATION 1A) SUBSTRATE SOLUTION BRING ALL REAGENTS TO ROOM TEMPERATURE (18° - 25° C) BEFORE PREPARING THE WORKING REAGENT. ADD THE ENTIRE CONTENTS OF THE SUBSTRATE RECONSTITUENT (100 ML) TO THE LYOPHILIZED SUBSTRATE AND MIX THOROUGHLY TO DISSOLVE THE SOLID MATERIAL. 1B)WASH SOLUTION ADD THE ENTIRE CONTENTS OF THE WASH CONCENTRATE (100 ML) TO APPROXIMATELY 2.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 2.5 L. 1C) DILUENT ADD THE ENTIRE CONTENTS OF THE DILUENT CONCENTRATE (100 ML) TO APPROXIMATELY 4.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 5.0 L. 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, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. · THE THREE 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 STRICTEST REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. THE ST AIA-PACK FT3 & FT4 ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: PROCEDURE REAGENT PREPARATION 1A) SUBSTRATE SOLUTION BRING ALL REAGENTS TO ROOM TEMPERATURE (18° - 25° C) BEFORE PREPARING THE WORKING REAGENT. ADD THE ENTIRE CONTENTS OF THE SUBSTRATE RECONSTITUENT (100 ML) TO THE LYOPHILIZED SUBSTRATE AND MIX THOROUGHLY TO DISSOLVE THE SOLID MATERIAL. 1B) WASH SOLUTION ADD THE ENTIRE CONTENTS OF THE WASH CONCENTRATE (100 ML) TO APPROXIMATELY 2.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 2.5 L. 1C) DILUENT ADD THE ENTIRE CONTENTS OF THE DILUENT CONCENTRATE (100 ML) TO APPROXIMATELY 4.0 L OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER, MIX WELL, AND ADJUST THE FINAL VOLUME TO 5.0 L. 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, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. · THE THREE 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO OPERATOR ERROR: IMPROPER REAGENT PREPARATION.
TOSOH BECAME AWARE THAT DURING A PROFICIENCY TESTING PERFORMANCE WITH SURVEY SAMPLES, THE CUSTOMER FAILED THE INSULIN (IRI), VITAMIN D (VIT. D), PROGESTERONE (PROG III) AND INTACT PARATHYROID HORMONE (IPTH) ANALYTES ON THE AIA-900 INSTRUMENT. THE ANALYTES RESULTS WERE OUT OF ACCEPTABLE RANGE. THE CUSTOMER STATED THE QUALITY CONTROL RESULTS PRIOR TO SURVEY SAMPLE RUN WERE WITHIN ACCEPTABLE RANGE. TECHNICAL SUPPORT SPECIALIST (TSS) SENT MAC CONTROLS FOR ESTRADIOL (E2), FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4) AND PROG III TO CUSTOMER FOR FURTHER INVESTIGATION. THE CUSTOMER PERFORMED QUALITY CONTROL RUN WHICH COMPLETED WITH OUT OF ACCEPTABLE RANGE RESULTS. TSS SENT VIT. D CONTROLS AND MAC CONTROLS TO CUSTOMER; THE CUSTOMER ALSO OBTAINED BIORAD CONTROLS. THE CUSTOMER ALSO RECEIVED A NEW SET OF PROFICIENCY TESTS AND WILL BE RUNNING AND SUBMITTING THE RESULTS WHEN THE CONTROLS ARE IN ACCEPTABLE RANGE. THE CUSTOMER CALIBRATED AND COMPLETED QUALITY CONTROL RUNS AND ALL RESULTS ARE WITHIN ACCEPTABLE RANGE. THE CUSTOMER INFORMED THE TSS THE FOLLOWING DAY THAT THE FT3 CONTROLS ARE OUT OF RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER INVESTIGATE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147402 | AIA-900 | AIA-900 | KHO | TOSOH CORPORATION | AIA-900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |