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

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

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer (fse) followed-up over-the-phone and instructed the customer to clean the sampling needle guide rod and run patient samples.The customer had also replaced the sampling needle assembly on (b)(6) 2018, the customer reported that after cleaning the sampling needle guide rod quality controls and patient samples were run without any issues.The customer reported that it was likely that the issue occurred due the sampling needle assembly being bent in addition to the dirty guide rod.The customer reported that no further issues were being experienced with the g8 instrument.No further action was required by the fse.A (b)(6) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no 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 710 z1-axis error an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The most probable cause of the reported event was due to a bent sampling needle assembly and dirty guide rod.(b)(4).

Event Description

On (b)(6) 2018, a customer reported getting 710 z-axis error messages on the g8 analyzer.The technical support specialist (tss) instructed to remove the brown cover from the analyzer and clean and lubricate the sampling needle assembly guide rods.The customer then proceeded to run five (5) patient samples without any errors.On (b)(6) 2018, the customer reported that the 710 z-axis error message persisted on the g8 analyzer.The tss sent a sampling needle assembly to the customer for replacement.On (b)(6) 2018, the customer reported that after replacing the sampling needle assembly the 710 z-axis error message persisted.The 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: 7471056
• MDR Text Key: 107211180
• Report Number: 8031673-2018-00365
• 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
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Distributor Facility Aware Date: 04/02/2018
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Date Manufacturer Received: 04/02/2018
• 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