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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8
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TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8 Back to Search Results
Model Number G8
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluation by manufacturer: field service engineering visited the customer to address to address the reported event.Fse was able to confirm the error.During further troubleshooting, fse suspected that the issue was related to power supply since the main circuit breaker had been tripped.Fse replaced the 12v switching power supply and the main circuit breaker was no longer tripping.Fse then found that the lcd touch function failed.Fse reloaded the software but the lcd touch screen was still working sporadically.Fse replaced the lcd screen, reloaded the software, and the touch display was working without any issues.Fse ran precision, calibration, and quality controls (qc) with acceptable results.Fse found that the column count was >2500 injections and advised the customer to replace the column after 2500 injections.The customer declined stating that they use the column up to 5000 injections as long as the qc values and pressure are within acceptable ranges.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 3, assay operations, states the following: if the main power switch is turned on and the screen does not display, or if an error is displayed, or some other event prevents the analyzer from activating the warming up sequence, turn off the main power switch.If the analyzer still doesn't start, contact technical support.The most probable cause of the reported event has not yet been determined.The investigation in progress.
 
Event Description
A customer reported that the display was not responding on start up on the g8 instrument.The customer stated that the screen would randomly change through the menu on its own.The customer tried to reboot the analyzer but it did not go past the introduction screen.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.
 
Manufacturer Narrative
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.Correction: device evaluation by manufacturer: it was noted in the previous device evaluation in mdr follow up 1, that the 12v switching power supply was visually examined and found to have an "exploded component" on the front end of the power supply.Please note that the component did not "explode" but was an opened capacitor causing an open circuit, which caused the switching power supply to fail.The most likely cause is due to the main circuit breaker tripping.The customer did not report any signs of smoke or sparks as a result of the event.
 
Manufacturer Narrative
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: the 12v switching power supply was returned to the instrument service center (isc) for evaluation.Upon visual examination, there was no shipping damage noted.However, there was an exploded component noted on the front end of the power supply.Functional testing was performed and found a shorted input (110v ac).The part failed visual and functional testing.The reported failure was confirmed.Evaluation codes: method:: 4109 historical data analysis, 10 test of actual/suspected device.Results: electrical/electrical component problem identified.Conclusion: 4307 cause traced to component failure.The most probable cause of the reported event was due to failure of the 12v switching power supply.
 
Manufacturer Narrative
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.Concomitant medical products: part returned for evaluation on 26-sept-2018.The lcd display was returned for evaluation.Functional testing was performed on the part by running whole blood samples.The error could not be duplicated.The part testing.
 
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Brand Name
TOSOH HLC-723G8 ANALYZER G8
Type of Device
G8
Manufacturer (Section D)
TOSOH CORPORATION
shiba-koen first building
3-8-2 shiba
minato-ku, tokyo 10586 23
JA  1058623
MDR Report Key7943380
MDR Text Key125127641
Report Number8031673-2018-00921
Device Sequence Number1
Product Code LCP
Combination Product (y/n)N
PMA/PMN Number
K131580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG8
Device Catalogue Number021560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2019
Distributor Facility Aware Date12/18/2018
Device Age5 YR
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer01/01/2019
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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