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 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: a field service engineer (fse) followed-up with the customer over-the-phone and confirmed that total area on qc was in range after the customer replaced the sample needle assembly.No further action was required by the fse.The g8 analyzer was performing within expected specifications.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 01-may-2017 through aware date (b)(4) 2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: 1.8 limitations of the procedure.Total area: dilution studies demonstrate that the assay is linear from a total area of 500 to 4000.However, the optimum total area is 700 to 3000.Chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.Chapter 6, troubleshooting, states the following: 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.200 area low error: three successive results below the lower limit of the total area (50) occur.If the error message is present when sufficient volume of sample is set in the rack, the problem may be caused by an empty reagent (hemolysis & wash solution).Check the remaining volume of hemolysis & wash solution and start the assay again.706 syringe-l error, explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.The most probable cause of the reported event was due to failure of the sample needle assembly.(b)(4).

Event Description

A customer reported receiving out of range low quality controls (qc) and "200 area low error" message with the g8 analyzer.The customer checked the waste bottle and it was not backing up.The technical support specialist (tss) instructed the customer to replace the sample needle assembly.After replacing the sample needle assembly the customer reported running qc with no errors being generated by the g8 analyzer.At a later date the customer reported low total area on qc.The customer uses 1500 ul wash to 10 ul qc.The tss instructed the customer to use 1000 ul wash and 10 ul of qc and rerun.The customer stated that after rerunning qc the issue persisted.The customer also stated getting occasional 706 l-syringe error messages as well.The customer requested service.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.

• 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 (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: 8242412
• MDR Text Key: 134466581
• Report Number: 8031673-2018-05322
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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: 01/11/2019
• Distributor Facility Aware Date: 06/01/2018
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2019
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2010
• 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