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

Model Number G8

Device Problem Computer Software Problem (1112)

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

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address to address the reported event.During servicing, fse verified the analyzer was unable to self load software into the system due to power outage over the weekend.Fse then reloaded the system program using a smart media card and verified parameters.Fse then verified back up batteries were working by unplugging the analyzer and verifying the software was not lost.Fse then ran quality controls (qc) with acceptable results.The instrument was operating as expected.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 03-nov-2017 through aware date 03-dec-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.System and as program downloading the as program (filename: as.Mot) and system program (filename: system.Mot) are required to operate the analyzer.Both of these programs are stored on the accessory system card.The most probable cause of the reported event was due to a power outage cause a minor software corruption.

Event Description

A customer reported getting an "as not found" message when turning on power on the g8 instrument.The customer stated that they arrived to a beeping noise and sampler searching system on the screen, corrupt.The customer tried to reboot but it did not resolve the issue.The customer did not have a memory card for the error.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: 8190588
• MDR Text Key: 132062242
• Report Number: 8031673-2018-05357
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 12/21/2018
• Distributor Facility Aware Date: 12/03/2018
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 12/21/2018
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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