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

Model Number G8

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address to address the reported event.During servicing, was able to confirm the issue.Fse was able to reproduce the issue by trying to power up the unit.Fse then reloaded the software version 5.23 with the smart card which was the version on the unit before the corruption.No parameters were lost.Fse then performed quality controls (qc) and ran two patient samples with acceptable results.Fse then adjusted retention times as the qc sa1c was eluting off at 0.63 minutes.Fse then adjusted the flow factor from 1.04 ml/min to 1.08 ml/min.The retention time went down to 0.59-0.60 minutes for qc and 0.60 for patient samples.Fse performed calibration which passed with acceptable results.The instrument was verified as operational.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 14-oct-2017 through aware date (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 7 data management, states the following: the analyzer's system program and assay parameters are backed up by the internal battery.When a system program version has been upgraded or some problem has corrupted the system program, use the following procedure to reload the program and other data from the smart media socket.The most probable cause of the reported event was due to a facility power outage that caused the software to be corrupted.Additionally, the flow rate needed an adjustment.

Event Description

A customer reported that the g8 instrument would not power on after a power outage at the facility.The instrument was giving a "system corrupted" message.The customer was unable to locate the system card.The instrument was down.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 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: 8144701
• MDR Text Key: 130635430
• Report Number: 8031673-2018-05225
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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: 12/07/2018
• Distributor Facility Aware Date: 11/14/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/07/2018
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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