AIA-900
Report
- Report Number
- 8031673-2018-05368
- Event Type
- Malfunction
- Date Received
- January 5, 2019
- Date of Event
- December 7, 2018
- Report Date
- January 19, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. D10 DATE RETURNED TO MANUFACTURER: 20-DEC-2018.
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: THE 3-WAY SUBSTRATE VALVE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE PART BY RUNNING THE DAILY CHECK WHICH RESULTS IN A FAILED DAILY TEST. THE REPORTED PROBLEM WAS DUPLICATED. THE PART FAILED TESTING.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE VERIFIED THE FLAGS ON THE PRINTOUT. FSE THEN REPLACED THE SOLENOID VALVE AND VERIFIED PROPER SUBSTRATE DELIVERY. FSE THEN CLEANED THE DETECTOR LENS, INCUBATOR, INCUBATOR ROTOR, AND THE SAMPLE NOZZLE AS PRECAUTION. FSE ALSO PERFORMED A REPAIR TO A LEAKING WASH PROBE #2. FSE TEN RECALCULATED THE BACKGROUND (BG) INITIAL REFERENCE AND CHANGED IT FROM 182 TO 111. THE CUSTOMER THEN RAN QUALITY CONTROLS WITHOUT ANY ERRORS. THE INSTRUMENT WAS PERFORMING AS EXPECTING. 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 (B)(6) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE TWO (2) SIMILAR COMPLAINTS, INCLUDING THIS EVENT, FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERROR MESSAGES STATES THAT A DL FLAG INDICATES A "FAULT HAS OCCURRED IN THE DETECTOR OR THE SUBSTRATE FEED LINE". ACCORDING TO CHAPTER 5, PERIODIC MAINTENANCE, THE DETECTOR REQUIRES CLEANING OF THE GLASS PLATE. IT MUST NOT BE DIRTY OR CLOUDY. IT MUST BE CLEANED WITH ALCOHOL. THE MOST PROBABLE CAUSE OF THE DETECTOR LOW (DL) FLAG WAS DUE TO A BAD SOLENOID VALVE.
A CUSTOMER REPORTED A DETECTOR LOW (DL) FLAG ON THE CONTROLS WITH THE AIA-900 INSTRUMENT. THE CUSTOMER REPORTED THAT THEY DID NOT GET ANY RESULTS AFTER RUNNING 5 PATIENT SAMPLES THE NIGHT BEFORE. THE CUSTOMER STATED THAT THEY PUT THE SAMPLES IN THE REFRIGERATOR AND SHUT DOWN THE ANALYZER. THE NEXT DAY, THE CUSTOMER PUT ALL NEW REAGENTS AND SUBSTRATE ON THE ANALYZER. THE DAILY CHECK PASSED AND THE CUSTOMER RAN QUALITY CONTROLS BUT THEY ALL HAD DL FLAGS. TECHNICAL SUPPORT (TS) INSTRUCTED THE CUSTOMER TO REPLACE THE SUBSTRATE WHICH PASSED WITHOUT ANY FLAGS. THE CUSTOMER THEN REPEATED THE DAILY CHECK AND IT PASSED. HOWEVER, WHEN THE CUSTOMER TRIED RUNNING ABOUT 20 PATIENT SAMPLES, THE DL FLAG RETURNED. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF ESTRADIOL (E2), FOLLICLE-STIMULATING HORMONE (FSH), LUTEINIZING HORMONE (LHII), PROGESTERONE (PROG II), AND PROLACTIN (PRL) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13220 | AIA-900 | AIA-900 | KHO | TOSOH CORPORATION | AIA-900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |