MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. (OHIO) G8; HEMOGLOBIN A1C TEST SYSTEM

Model Number	HLC-723G8 REFURBISHED
Medical Device Problem Codes	No Audible Alarm (1019); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fse opened the analyzer and noticed the 24/5v board had visible burn marks.There was no fluid on the board that would initiate the fire.The analyzer was de installed immediately and removed from the customer¿s site and returned to tosoh instrument service center for further investigation.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2021 through aware date (b)(6) 2022.There were no similar complaints identified during the search period.The most probable cause of the reported event is not determined; cause not established.
Event or Problem Description
While the tosoh field service engineer (fse) was at the customer¿s site performing a periodic maintenance (pm) on the g8 analyzer, the analyzer made an audible popping and sizzling sound during a drain flush.The sorter no longer recognizes the sensor and wisps of smoke was observed from the front of the analyzer.No flames observed and no injuries to the users or the field service engineer (fse) was reported.The analyzer is down.
Additional Manufacturer Narrative
A product evaluation was performed in response to the g8 analyzer with visible burn marks on the boards and smoke coming from the front of the analyzer.The analyzer was returned to tosoh instrument service center (isc) for investigation.Isc evaluated g8 analyzer with visual inspection and found no damage.Functional testing was performed, which confirmed the reported g8 would not power up correctly with a loader attached due to electrical problem.The cb1 cable had 3 lines shorted together exhibited electrical shorting.The most probable cause of the reported event was cause traced to component failures.

• Brand Name: G8
• Common Device Name: HEMOGLOBIN A1C TEST SYSTEM
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 15639470
• Report Number: 3005529799-2022-00030
• Device Sequence Number: 12391782
• Product Code: PDJ
• UDI-Device Identifier: 00853931008009
• UDI-Public: 00853931008009
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HLC-723G8 REFURBISHED
• Device Catalogue Number: 021560R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown