TOSOH HLC-723G8 ANALYZER
Report
- Report Number
- 8031673-2017-00300
- Event Type
- Malfunction
- Date Received
- January 17, 2018
- Date of Event
- December 20, 2017
- Report Date
- October 25, 2018
- Manufacturer
- TOSOH CORPORATION
- Product Code
- LCP
- PMA / PMN Number
- K131580
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
- Health Professional
- Yes
Narratives
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 21-DEC-2017 A FIELD SERVICE ENGINEER (FSE) FOUND UPON ARRIVAL THAT THE G8 INSTRUMENT HAD BEEN RUNNING THE NIGHT SHIFT WITH NO HIGH TOTAL AREA. THE CUSTOMER HAD RUN 85 PATIENT SAMPLES. IT APPEARED THAT THE NIGHT SHIFT CREW HAD CHANGED THE ELUTION BUFFERS DURING THE RUN WHEN THE ERROR OCCURRED. THE FSE RAN QUALITY CONTROLS, WHICH WERE WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION WAS REQUIRED BY THE FSE. THE G8 INSTRUMENT WAS FUNCTIONING AS INTENDED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE G8, SERIAL NUMBER (B)(4), FROM 20-NOV-2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1 - INTRODUCTION AND APPLICATIONS, STATES: TOTAL AREA (TA) IN THE RANGE OF 700-3000. HOWEVER A TA IN THE RANGE OF 500-4000 IS ACCEPTABLE AND REPORTABLE FOR WHOLE BLOOD SPECIMENS. TOTAL AREA DILUTION STUDIES DEMONSTRATE THAT THE ASSAY IS LINEAR FROM A TOTAL AREA OF 500 TO 4000. HOWEVER, THE OPTIMUM TOTAL AREA IS 700 TO 3000. STEP 1.6 PROCEDURES, INSTALLING G8 VARIANT ELUTION BUFFER HIS, PROVIDES STEP-BY-STEP INSTRUCTIONS ON INSTALLING THE ELUTION BUFFERS. CHAPTER 6, TROUBLESHOOTING, SECTION 6.1 ASSAY PRECAUTIONS, STATE THE FOLLOWING: ELUTION BUFFERS - BE SURE TO READ THE INSTRUCTIONS FOR USE ENCLOSED IN THE ELUTION BUFFER BOX, AS WELL AS THIS MANUAL. - BE SURE NOT TO USE ANY OTHER BUFFER THAN THE BUFFER FOR THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8. USE THE ELUTION BUFFERS BEFORE THE EXPIRATION DATE INDICATED ON THE LABEL. - ALWAYS USE THE G8 VARIANT ELUTION BUFFER(S) HSI IN COMBINATION WITH A TSKGEL G8 VARIANT HSI COLUMN OF THE IDENTICAL LOT NUMBER. - DO NOT REFILL THE ELUTION BUFFER OR USE IT WITHOUT ENSURING THAT THE LOT NUMBERS ARE THE SAME. THE MOST PROBABLE CAUSE WAS DUE TO AN OPERATOR ERROR WHILE INSTALLING THE ELUTION BUFFERS.
PLEASE NOTE THAT THIS MDR MFR REPORT #: MDR 8031673-2017-00300 / IMPORTER REPORT #: 3005529799-2017-00308 WAS PREVIOUSLY SUBMITTED TO THE FDA ON (B)(6)2018; IT WAS RECREATED AS MFR REPORT #: 8031673-2017-00300 PER REQUEST BY THE FDA MDR DATA SYSTEMS TEAM REPRESENTATIVE. 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. H3. DEVICE EVALUATION BY MANUFACTURER: FSE (FIELD SERVICE ENGINEER) WENT ON SITE ON (B)(6) 2017 NOT (B)(6) 2017 AS STATED IN INITIAL SUBMISSION.
ON (B)(6) 2017 A CUSTOMER REPORTED GETTING HIGH TOTAL AREA ON WHOLE BLOOD SPECIMENS WITH THE G8 INSTRUMENT. THE CUSTOMER STATED THAT TOTAL AREA ON QUALITY CONTROLS WAS WITHIN ACCEPTABLE RANGE. THE CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE REPORTED ISSUE. 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 WAS 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 |
|---|---|---|---|---|---|---|---|
| 44584 | TOSOH HLC-723G8 ANALYZER | G8 | LCP | TOSOH CORPORATION | G8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |