MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER

Model Number G8

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 04-apr-2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse verified the 711 line valve error through the instrument's error log.Fse replaced the asm pcb board and verified proper operation.Fse ran precision, quality controls (qc), and patient samples.All results were with acceptable range and the error cleared.The g8 instrument was performing as intended.No further action was required from field service.A (b)(4) complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through the awareness date (b)(6) 2018 for similar complaints was performed.There were two (2x) other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 6.3 error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.The 711 line valve error: explanation: operation error in switching valve (as valve) countermeasure: inspect valve on line.Execute smp.Reset.The most probable cause of the reported event was due to defective asm board.

Event Description

On (b)(6) 2018, a customer reported getting message 711 line valve while running quality controls (qc) on the g8 instrument.Customer stated the error persists despite rebooting.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.

Manufacturer Narrative

Corrections: the initial report stated (b)(6) 2018.The correct date is (b)(6) 2018.The initial report stated (b)(6) 2018 as the date of fse dispatch.The correct date is (b)(6)2018.Device evaluation by manufacturer: the asm board was received for in-house investigation.Functional and linearity chemistry tests were performed.Investigation of the board could not duplicate the reported message 711 line valve error.The board functions as specified.The linearity test also resulted within acceptable range in all required levels of quality control testing.The most probable cause of the reported event could not be determined.

Event Description

N/a.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7477754
• MDR Text Key: 107590488
• Report Number: 8031673-2018-00368
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2018
• Distributor Facility Aware Date: 04/13/2018
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/08/2018
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1