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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.Fse conducted follow-up with the customer over-the-phone to address the reported event.The fse advised the customer to clean the shaft and screw drive for the z1 axis with alchohol.Then the fse instructed the customer on removing the needle for cleaning.After cleaning the shaft and screw drive the fse instructed the customer on how to lube the shaft and screw drive with triflow.The customer ran more than twenty samples after the re-assembly of the needle.The run went to completion without any errors.Instrument is functioning as intended and was released.No further action is required by the fse.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the (b)(6) 2017 through awareness date on the (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 710 z1-axis error explanation: operation error in z1-axis.Countermeasure: inspect z1-axis.Execute smp.Reset.The most probable cause of the reported issue was due to the sample z axis requiring lubrication.(b)(4).

Event Description

The customer reported receiving frequent 710 z1 axis errors on their g8 instrument.Customer indicated they have changed the sample needle and cleaned the guide rod which resolved the problem for a few days but the error returned.The technical support specialist (tss) advised the customer to perform a smp reset and a rack rotate which were completed without any errors.The customer reported that during smp reset procedure the needle seems to vibrate before the reported error occurs.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.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
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• 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, CA 94080 ; 6506368123
• MDR Report Key: 7547249
• MDR Text Key: 109904669
• Report Number: 8031673-2018-00486
• 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: 05/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2018
• 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: 05/27/2018
• Distributor Facility Aware Date: 05/07/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/27/2018
• Date Manufacturer Received: 05/07/2018
• 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