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 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.Fse confirmed the errors and was able to reproduce them.Inspection of the device revealed there was a leak at the prefilter housing.Fse tightened the prefilter housing and the leak was resolved.Next, fse adjusted the flow rate to 1.10 ml/min for sa1c retention time of 0.59 minute, calibrated with calibrator lot #zs7001, and ran quality control (qc).No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 10nov2017 through aware date (b)(4) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 4 screen operations & chapter 6, troubleshooting, states the following: 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.Peak pattern error: explanation: peaks were not separated well.Countermeasure: check the samples, buffers, and hemolysis & wash solution.The most probable cause of the reported event was due to a loose filter housing.

Event Description

It was reported that the customer received "211 peak pattern" errors on their g8 analyzer.The customer stated that the column was new and had a count of 106 injections.Technical support (ts) instructed the customer to adjust the flow rate from 1.08 ml/min to 1.14 ml/min.The customer ran five prime samples and the retention time (rt) was 0.65 "miunute".Ts had the customer adjust the flow rate to 1.18 ml/min and run the same prime samples.The rt was still 0.65 minutes.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.

• 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: 8205354
• MDR Text Key: 132505068
• Report Number: 8031673-2018-05376
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2018
• 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: 12/29/2018
• Distributor Facility Aware Date: 12/10/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/29/2018
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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