AIA-2000
Report
- Report Number
- 8031673-2018-05258
- Event Type
- Malfunction
- Date Received
- January 2, 2019
- Date of Event
- December 4, 2018
- Report Date
- January 12, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
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. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE CONFIRMED THE ISSUE BY THE QUALITY CONTROL (QC) LEVY JENNINGS CHARTS. FSE OBSERVED THAT THE CUSTOMER REPRODUCED THE ERROR ON MULTIPLE QC RUNS WITH MULTIPLE ANALYTES. FSE FLUSHED THE SAMPLE NOZZLE WITH ALCOHOL AND OBSERVED PARTICLES/BLOCKAGE. FSE THEN REPLACED THE SUBSTRATE SYRINGE AND THE SOLENOIDS. FSE THEN PERFORMED DECONTAMINATION AND VERIFIED TRIIODOTHYROXINE (TT3) CALIBRATION AND PRECISION WITH ACCEPTABLE RESULTS. HOWEVER, THE QUALITY CONTROLS WERE RUN BY THE CUSTOMER THE NEXT DAY AND WERE OUT OF RANGE. FSE RETURNED TO THE SITE AND REPLACED THE SAMPLE NOZZLE AND SAMPLE SYRINGE, WHICH RESOLVED THE ISSUE. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. DATE RETURNED TO MANUFACTURE: 24-DEC-2018. THE SAMPLE NOZZLE ASSEMBLY WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE PART WITH A LIGHT AND A MAGNIFYING GLASS WHICH REVEALED THAT THE NOZZLE PASSAGE WAS MOSTLY BLOCKED WITH AN UNKNOWN SUBSTANCE. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE ISSUE WAS IDENTIFIED WITH VISUAL INSPECTION. THE PART FAILED VISUAL INSPECTION. THE REPORTED EVENT WAS CONFIRMED.
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) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE CONFIRMED THE ISSUE BY THE QUALITY CONTROL (QC) LEVY JENNINGS CHARTS. FSE OBSERVED THAT THE CUSTOMER REPRODUCED THE ERROR ON MULTIPLE QC RUNS WITH MULTIPLE ANALYTES. FSE FLUSHED THE SAMPLE NOZZLE WITH ALCOHOL AND OBSERVED PARTICLES/BLOCKAGE. FSE THEN PERFORMED DECONTAMINATION AND VERIFIED TRIIODOTHYROXINE (TT3) CALIBRATION AND PRECISION WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 10424810 AND FREE THYROXINE (FT4) LOT 096 FROM 04-NOV-2017 THROUGH AWARE DATE 04-DEC-2018. THERE WERE TWO (2) SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS STATES THE FOLLOWING: ONLY PERSONNEL WITH SUFFICIENT KNOWLEDGE OF IMMUNOLOGICAL ASSAY TECHNIQUES AND THE PROCEDURES FOR HANDLING INFECTIOUS WASTE MATERIALS SHOULD BE ALLOWED TO OPERATE THE AIA-2000. - THERE IS ALWAYS THE POSSIBILITY THAT BLOOD AND BODY FLUID MAY HAVE BEEN CONTAMINATED BY INFECTIOUS AGENTS. MISTAKES IN SYSTEM OPERATION AND HANDLING OF SUCH MATERIALS CAN RESULT IN THE TRANSMISSION OF INFECTIOUS AGENTS TO THE SYSTEM OPERATOR AND/OR TO NEARBY PERSONNEL. IT IS RECOMMENDED THAT ALL SPECIMENS BE HANDLED WITH THE UTMOST OF CARE AND THAT THE PROPER PROTECTIVE CLOTHING (GOGGLES, GLOVES, MASKS ETC.) BE USED AT ALL TIMES DURING MAINTENANCE PROCEDURES. - ALL SPECIMEN CONTAINERS, INCLUDING USED TEST CUPS, SAMPLE TIPS, REAGENT BOTTLES, SAMPLE CUPS AND WASTE FLUIDS MAY HAVE BEEN CONTAMINATED BY BLOOD AND BODY FLUID. IT IS RECOMMENDED THAT PROPER PROTECTIVE CLOTHING (GOGGLES, GLOVES, MASKS ETC.) BE WORN AT ALL TIMES AND THAT WASTE MATERIALS BE DISPOSED OF IN ACCORDANCE WITH THE FOLLOWING DIRECTIVES AND ALL OTHER RELEVANT LAWS AND REGULATIONS TO PROTECT ALL PERSONNEL IN THE GENERAL OPERATING VICINITY AND THE SURROUNDING ENVIRONMENT. THE AIA-PACK B12 ANALYTE APPLICATION MANUAL (AAM) STATES THE FOLLOWING: CALIBRATION THE CALIBRATORS FOR USE WITH THE AIA-PACK B12 ARE PREPARED GRAVIMETRICALLY AND ARE COMPARED TO INTERNAL REFERENCE STANDARDS. THE CALIBRATION CURVE FOR THE AIA-PACK B12 IS STABLE FOR UP TO 30 DAYS. CALIBRATION STABILITY IS MONITORED BY QUALITY CONTROL PERFORMANCE AND IS DEPENDENT ON PROPER REAGENT HANDLING AND AIA SYSTEM MAINTENANCE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. RECALIBRATION MAY BE NECESSARY MORE FREQUENTLY IF CONTROLS ARE OUT OF THE ESTABLISHED RANGE FOR THIS ASSAY OR IF CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, OR DETECTOR LAMP ADJUSTMENT OR CHANGE). RECALIBRATION IS NECESSARY IF THERE IS A CHANGE IN THE LOT NUMBER OF THE B12 PRETREATMENT SET. FOR FURTHER INFORMATION REGARDING INSTRUMENT OPERATION, CONSULT THE AIA SYSTEM OPERATOR'S MANUAL. CALCULATION OF RESULTS THE AIA SYSTEMS PERFORM ALL SAMPLE AND REAGENT HANDLING OPERATIONS AUTOMATICALLY. THE AIA SYSTEMS READ THE RATE OF FLUORESCENCE PRODUCED BY THE REACTION AND AUTOMATICALLY CONVERT THE RATE TO VITAMIN B12 CONCENTRATION IN PG/ML. FOR SAMPLES REQUIRING DILUTION, THE AIA SYSTEM WILL AUTOMATICALLY PERFORM DILUTIONS AND CALCULATE RESULTS IF THE DILUTION FACTORS ARE ENTERED INTO THE SOFTWARE. DILUTION FACTORS MAY BE ENTERED WHEN PROGRAMMING THE SPECIMENS. 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 DISCREPANT SAMPLES AND FLUCTUATING QUALITY CONTROL RESULTS WAS DUE TO A BLOCKED SAMPLE NOZZLE AND THE INSTRUMENT REQUIRED DECONTAMINATION.
A CUSTOMER REPORTED THAT THEY FAILED TWO OUT OF THREE B12 AMERICAN PROFICIENCY INSTITUTE (API) SURVEY SAMPLES ON THE AIA-2000ST INSTRUMENT. THE CUSTOMER REPEATED THE STUDY AND ALL THREE SPECIMENS WERE IN ACCEPTABLE RANGE. THE CUSTOMER INITIALLY REPORTED THE B12 USING LOT 48, BUT WHEN THE SURVEY WAS REPEATED, THEY USED LOT 053 THAT WAS CALIBRATED NEARLY A MONTH PRIOR. THE CUSTOMER PROVIDED THE CALIBRATION CURVES FROM BOTH REAGENT LOTS AND BIORAD (BR) QUALITY CONTROL (QC) LOT 40340, WHICH WAS BELOW THE MEAN BUT WITHIN ACCEPTABLE RANGE. API CHEM-MISC-2ND EVENT WAS REPORTED FOR B12: IA 04 - 562 PG/ML AND WHEN RERUN - 1039 PG/ML [818-1388 PG/ML], IA 05 - 612 PG/ML AND WHEN RERUN - 916 PG/ML [722- 1094 PG/ML], IA 06 - 563 PG/ML AND WHEN RERUN - 663 PG/ML [514-822 PG/ML]. THE CUSTOMER PROVIDED QC (B)(6) USING BR 40340 PEER DATA FOR ACCEPTABLE RANGES. ALL B12 QC WERE IN RANGE BUT BELOW THE MEAN. THE CUSTOMER REPORTED THAT THE INSTRUMENT HAD A PERIODIC MAINTENANCE AND B12 CALIBRATION RIGHT BEFORE THE API SURVEY. THE TECHNICAL SUPPORT SPECIALIST (TSS) SUGGESTED PERFORMING A PRECISION STUDY TO CHECK THE SAMPLING BUT THE CUSTOMER REPORTED THAT THE FREE THYROXINE (FT4) QC WAS HIGH AND PARATHYROID HORMONE (PTH) QC WAS OUT LOW. THE CUSTOMER STATED THAT THEY RECALIBRATED FT4 LOT 096 BECAUSE THE QC FOR LEVEL 1 WAS 1.73 NG/ML [0.69-1.28 NG/ML] AND LEVEL 2 WAS 6.88 NG/ML [ 3.48-6.46 NG/ML]. THE CUSTOMER DID NOT REPEAT QC WITH FRESH QC BUT CALIBRATED LOT 96 WITH A RATE ONE RESULT OF 22.23 NG/ML AND THE QA'S RESULT WAS 27.3 NG/ML. THE BR 40340 QC RESULTS FOR LEVEL 1 WAS 1.01 NG/ML AND LEVEL 2 WAS 5.05 NG/ML. THE CUSTOMER REPEATED FOUR FT4 PATIENT SAMPLES (FROM THE PREVIOUS NIGHT) WITH HIGH RESULTS USING THE NEW CALIBRATION: INITIAL, REPEAT: 1.63 NG/DL, 1.00 NG/DL (REPEAT RESULT WITHIN NORMAL RANGE); 1.64 NG/DL, 1.22 NG/DL (REPEAT RESULT WITHIN NORMAL RANGE); 1.81 NG/DL, 1.50 NG/DL (REPEAT RESULT HIGH); 2.04 NG/DL, 1.72 NG/DL (BOTH RESULTS HIGH). THE CUSTOMER SENT OUT CORRECTED REPORTS BUT SAID THAT THE PATIENTS WERE NOT TREATED IN RESPONSE TO THE RESULTS FROM THE PREVIOUS NIGHT'S RESULTS. THE CUSTOMER REPORTED THAT THEY HAD BEEN FREEZING ALL PATIENT SAMPLES BECAUSE OF THE FLUCTUATING QC RESULTS. THE CUSTOMER DID NOT SEND ANY PTH DATA. THIS ANALYZER WAS DOWN. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT SURVEY RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2937 | AIA-2000 | AIA-2000 | KHO | TOSOH CORPORATION | AIA-2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |