AIA-900
Report
- Report Number
- 8031673-2017-00109
- Event Type
- Malfunction
- Date Received
- November 17, 2017
- Date of Event
- October 18, 2017
- Report Date
- May 17, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) RAN DAILY MAINTENANCE AND BACKGROUND CHECK, WHICH PASSED. THE FSE FOUND DID A SUBSTRATE REPLACEMENT AND FOUND AIR IN THE SUBSTRATE SYRINGE. THE FSE REMOVED AND RESEATED THE SUBSTRATE SYRINGE. THE FSE PROCEEDED TO RUN BACKGROUND, WHICH PASSED. THE FSE ATTEMPTED TO RUN QUALITY CONTROLS AND THE AIR IN THE SUBSTRATE SYRINGE PERSISTED. THE SUBSTRATE 3-WAY SOLENOID VALVE WAS STUCK, CAUSING AIR INTO THE SUBSTRATE SYRINGE. THE FSE REPLACED THE SUBSTRATE 3-WAY SOLENOID VALVE AND THE SUBSTRATE SYRINGE PROACTIVELY. THE FSE RAN CALIBRATION AND QUALITY CONTROLS, WHICH PASSED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: FLAGS ARE ATTACHED TO THE ASSAY RESULTS AS NECESSARY. FLAGS ARE CLASSIFIED AS "ERROR FLAGS" WHICH ARE ATTACHED WHEN ASSAY DID NOT END NORMALLY DUE TO SOME KIND OF TROUBLE, AND "USER FLAGS" (NORMAL VALUES, ABNORMAL VALUES) WHICH ENABLE THE USER TO JUDGE THE ASSAY RESULTS. DEPENDING UPON THE ERROR STATUS, THERE ARE CASES IN WHICH THE ERROR FLAGS ARE ATTACHED AND ASSAY RESULTS CAN BE OBTAINED AND CASES IN WHICH THEY ARE ATTACHED BUT ASSAY RESULTS CANNOT BE OBTAINED. IF NO FLAG IS ATTACHED TO THE ASSAY RESULT, IT MEANS THAT THE ASSAY ENDED NORMALLY. IF AN ERROR WAS DETECTED AND AN ASSAY RESULT WAS NOT OBTAINED, REFER TO THIS SECTION AND THE MEASURES FOR HANDLING SHOWN THERE. DL A FAULT OCCURRED IN THE DETECTOR OR THE SUBSTRATE FEED LINE. PRINT AND DISPLAY (RATE VALUE): OUTPUTS THE MEASUREMENT VALUES. PRINT AND DISPLAY (CONCENTRATION VALUE): BECOMES BLANK. RS232C OUTPUT (CONCENTRATION VALUE): CONFORMS TO THE SETTING THAT IS APPLICABLE TO THE CASE WHERE NO CONCENTRATION IS SET IN THE HOST. RS232C OUTPUT (FLAG): A THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE SUBSTRATE 3-WAY SOLENOID VALVE.
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. CORRECTED DATA: AGE OF DEVICE: 4 YEARS.
ON (B)(6) 2017 A CUSTOMER GETTING A DETECTOR LOW (DL) ERROR FLAG WHILE RUNNING PATIENT SAMPLES WITH THE AIA-900 INSTRUMENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON INTACT PARATHYROID HORMONE (IPTH). ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS IPTH. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.
(B)(4), PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820660 | AIA-900 | AIA-900 | KHO | TOSOH CORPORATION | AIA-900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |