TOSOH HLC-723G8 ANALYZER G8
Report
- Report Number
- 8031673-2018-05276
- Event Type
- Malfunction
- Date Received
- November 16, 2018
- Date of Event
- November 4, 2018
- Report Date
- June 14, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- LCP
- PMA / PMN Number
- K131580
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. H.3. DEVICE EVALUATION BY MANUFACTURER: THE PUMP ASSEMBLY WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE PART AND FOUND THAT IT HAD CORROSION DOWN THE FRONT IT. THIS IS LIKELY WHERE FLUID LEAKED BEHIND THE SEAL. THE PART FAILED TESTING. H6 EVALUATION CODES METHODS: 4190-HISTORICAL DATA ANALYSIS; 10-TESTING OF ACTUAL/SUSPECTED DEVICE, RESULTS: 180-MECHANICAL PROBLEM IDENTIFIED, CONCLUSION CODE: 4307-CAUSE TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT OF THE REPORTED ISSUE WAS DUE TO FAILURE OF THE PUMP ASSEMBLY.
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. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER 11198511 FROM 04-OCT-2017 THROUGH AWARE DATE 04-NOV-2018. THERE WAS ONE SIMILAR ADDITIONAL COMPLAINT FOUND DURING THE SEARCHED PERIOD. CORRECTED DATA: SEE SECTIONS: B5
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 ON THE PATIENT PRINTOUTS. FSE DISCOVERED THE ISSUE WAS RELATED TO THE PUMP AND REPLACED IT. FSE VERIFIED PROPER OPERATION WITHOUT ANY ERRORS. FSE THEN RAN CALIBRATION, PRECISION, AND QUALITY CONTROLS 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 11198511 FROM 04-OCT-2017 THROUGH AWARE DATE 04-NOV-2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATIONS, STATES THE FOLLOWING: THE TIME FROM INJECTION OF THE SAMPLE TO THE TIME THE SPECIFIC PEAK ELUTES OFF THE COLUMN IS CALLED RETENTION TIME. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 SOFTWARE HAS BEEN WRITTEN SO THAT EACH OF THE EXPECTED FRACTIONS HAS A WINDOW OF ACCEPTABLE RETENTION TIMES. IF THE DESIGNATED PEAK FALLS WITHIN THE EXPECTED WINDOW, THE CHROMATOGRAM PEAKS WILL BE PROPERLY IDENTIFIED. WHEN A PEAK ELUTES AT A RETENTION TIME NOT WITHIN A SPECIFIED WINDOW, AN UNKNOWN PEAK (P00) RESULTS. IF MORE THAN ONE PEAK ELUTES AT TIMES NOT SPECIFIED BY THE SOFTWARE WINDOWS, EACH IS GIVEN A SEQUENTIAL P0X TITLE. IN ORDER TO KEEP THE PEAKS WITHIN THEIR APPROPRIATE WINDOWS, IT MAY BE NECESSARY TO CHANGE HOW FAST OR SLOW THE BUFFERS ARE MOVING THROUGH THE SYSTEM BY CHANGING THE PUMP FLOW RATE. UNDER INTERPRETATION OF RESULTS: WHEN THERE IS A QUESTION CONCERNING THE CHROMATOGRAPHY, REPEAT THE SAMPLE. IF THE REPEATED SAMPLE ALSO DISPLAYS UNUSUAL CHARACTERISTICS, IT IS APPROPRIATE TO EVALUATE WHETHER THE UNUSUAL RESULT IS DUE TO AN ABNORMAL SAMPLE, A PROCEDURAL ERROR, AN INSTRUMENT MALFUNCTION OR A SAMPLE-HANDLING PROBLEM. FOR FURTHER INFORMATION, SEE THE TROUBLESHOOTING SECTION IN THIS OPERATOR'S MANUAL THE G8 VARIANT ANALYSIS MODE TRAINING MANUAL UNDER LESSON 8 - TROUBLESHOOTING, STATES THE FOLLOWING: ADJUSTING THE FLOW RATE - HOW AND WHY ON THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8; VARIANT ANALYSIS MODE IT MAY BE NECESSARY TO ADJUST THE FLOW RATE BECAUSE EITHER UNIDENTIFIABLE PEAKS APPEAR ON ALL THE CHROMATOGRAMS OR THE AVERAGE RETENTION TIME FOR VARIOUS PEAKS HAS CHANGED SIGNIFICANTLY. THE FLOW RATE IS CHANGED BY CHANGING THE FLOW FACTOR IN THE INSTRUMENT. THE FLOW FACTOR IS GENERALLY 1.00 ML/MIN. THE FLOW FACTOR SHOULD ONLY BE ADJUSTED +/- 0.05 OF THE DEFAULT FACTORY SETTING. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS HAS NOT YET BEEN DETERMINED. THE INVESTIGATION IS IN PROGRESS.
A CUSTOMER REPORTED ERRATIC RETENTION TIMES (RT) BETWEEN 0.53-0.66 MINUTES WHILE CALIBRATING ON THE G8 INSTRUMENT. THE COLUMN COUNT WAS AT 1122 INJECTIONS AND THE PRESSURE WAS 8.3 MPA. THE CUSTOMER CHANGED THE SAMPLE NEEDLE AS THEY DID NOT THINK IT WAS GETTING ANY OF THE SAMPLE. TECHNICAL SUPPORT (TS) INSTRUCTED THE CUSTOMER TO RUN FIVE SAMPLES TO CHECK THE RETENTION TIME .THE RETENTION TIME WAS 0.53 MINUTES ON THE FIRST SAMPLE AND IT WAS 0.65 MINUTES ON THE SECOND SAMPLE. THE CUSTOMER CALLED BACK A FEW DAYS LATER REPORTING THE SAME ISSUE. THE INSTRUMENT WAS DOWN. A 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 IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 918815 | TOSOH HLC-723G8 ANALYZER G8 | G8 | LCP | TOSOH CORPORATION | G8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |