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 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer followed-up over-the-phone and instructed the customer to drain flush in order to duplicate the 706 syringe-l error messages on the g8 instrument.The fse instructed the customer to clean the large syringe spiral lead screw and drain flush again to ensure that the 706 syringe-l error message was no longer being generated.The fse sent the customer a bottle of tri-flow lubricant to lubricate the large syringe spiral lead screw.The customer reported that the g8 was performing within manufacturer's specifications; no further action was required by the fse.A (b)(6) complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.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 706 syringe-l error: explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.Errors that do not interrupt the assay run.When the following errors occur, a message will be displayed, but the assay will continue.The 140 buffer empty: the remaining reagent is low.A message will be displayed only if the alarm is set.The most probable cause of the reported issue was due to a dirty large syringe lead screw.(b)(4).

Event Description

On (b)(6) 2018, a customer reported getting 706 syringe-l and 140 buffer empty error messages on the g8 instrument.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: 7449284
• MDR Text Key: 106742723
• Report Number: 8031673-2018-00337
• 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: 04/20/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Distributor Facility Aware Date: 03/27/2018
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2011
• 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