TOSOH HLC-723G8 ANALYZER
Report
- Report Number
- 8031673-2017-00186
- Event Type
- Malfunction
- Date Received
- December 19, 2017
- Date of Event
- November 20, 2017
- Report Date
- January 5, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- LCP
- PMA / PMN Number
- K131580
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. PLEASE NOTE, FOLLOW UP #2 INCORRECTLY LISTED. APPROX AGE OF DEVICE AS 4 YEARS. THE CORRECT AGE OF DEVICE IS 5 YEARS. ALSO PLEASE NOTE, THAT THE INITIAL, FOLLOW UP #1, AND FOLLOW UP #2 MDR SUBMISSIONS INCORRECTLY NOTED. DEVICE MANUFACTURE DATE AS 01-OCT-2012. THE CORRECT DEVICE MANUFACTURE DATE WAS 01-SEPT-2012.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOUND THE PEEK TUBING WAS NOT PUSHED ALL THE WAY THROUGH THE FINGER NUT. FSE PUSHED THE TUBING THROUGH THE FINER NUT AND THE ISSUE WAS RESOLVED. THE FSE THEN PROCEEDED TO RUN QUALITY CONTROLS, WHICH PASSED WITHOUT ANY ISSUES. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER'S FACILITY. FSE VERIFIED THE SYRINGE ASSEMBLY FOR ERROR 706. FSE THEN VERIFIED CORRECT PERFORMANCE OF THE SENSORS AND MOTOR, CLEANED AND LUBRICATED THE SYRINGE ASSEMBLY. THE FSE THEN RAN QUALITY CONTROLS (QC) AND ALL PASSED WITHOUT ANY ISSUES. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6, TROUBLESHOOTING, STATES MESSAGE 706 IS SYRINGE-L ERROR AND IS OPERATION ERROR IN SYRINGE-L. THE COUNTERMEASURE IS FOR THE USER TO INSPECT THE SYRINGE-L AND EXECUTE SMP.RESET. THE MOST PROBABLE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THE INSTRUMENT WAS CLEANED AND LUBRICATED AND WORKING AS INTENDED.
ON (B)(6) 2017 A CUSTOMER REPORTED GETTING INTERMITTENT ERROR 706 SYRINGE-L ERROR DURING START UP ON THE G8. ON (B)(6) 2017 FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C). THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.
PLEASE DISREGARD THE FOLLOWING INFORMATION AS IT WAS INCORRECTLY REPORTED IN THE ORIGINAL SUBMISSION: "ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) FOUND THE PEEK TUBING WAS NOT PUSHED ALL THE WAY THROUGH THE FINGER NUT. FSE PUSHED THE TUBING THROUGH THE FINER NUT AND THE ISSUE WAS RESOLVED. THE FSE THEN PROCEEDED TO RUN QUALITY CONTROLS, WHICH PASSED WITHOUT ANY ISSUES. THE G8 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. "
CORRECTED DATA: INITIAL REPORT, THE FSE DISPATCHED DATE WAS (B)(6) 2017. THE CORRECTED DATE IS (B)(6) 2017.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 909939 | TOSOH HLC-723G8 ANALYZER | G8 | LCP | TOSOH CORPORATION | G8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |