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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The distributor field service engineer (fse) instructed the customer to replace the filter.Quality controls and samples were run, which passed.No further action was required.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 17nov2017 through 17dec2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 1- introduction & applications & chapter 6, troubleshooting states the following: general 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.With these errors, the assay stops and the analyzer immediately enters stand-by state.102 pres limit over: the pump pressure has risen abnormally and has caused the shutdown circuit to be activated.Turn the main power switch off and remove the cause of the pressure increase.Refer to 100 pressure high.150 grad sensor error: the grad sensor on the pump has malfunctioned.The operator is instructed to check the grad sensor.The most probable cause of the reported event was due to a worn filter.

Event Description

It was reported that the customer received the "150 grad sensor" error with their g8 analyzer.The analyzer was down.The distributor field service engineer was dispatched to address the reported event, which resulted in a 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.

• 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 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH CORPORATION; 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,
• MDR Report Key: 8255546
• MDR Text Key: 134596002
• Report Number: 8031673-2019-00008
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2018

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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2018
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/16/2018
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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