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

Model Number G8

Device Problem Computer Operating System Problem (2898)

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

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016, a field service engineer (fse) visited the client site and replaced the defective all in one computer with its reporting software.He also loaded the printer driver and the keyspan usb serial driver.He tested the unit and the data transfer capability from the g8 to the reporting software and then to the laboratory information system (lis).The fse set up the computer according to work instructions 12-css-042-0 rev 13.In addition, he removed the hard drive from the defective computer and gave it to customer so that the client disposes of it according to their protocols.No further action was required by field service.The most probable cause of the reported event was defective all in one computer.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).

Event Description

On (b)(6) 2016, a customer reported a computer failure with their hlc-723g8 analyzer.The computer was in a repair-and-repeat startup repair cycle repeatedly.The customer was unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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 (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: 7347797
• MDR Text Key: 103152618
• Report Number: 8031673-2018-03172
• 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: 03/18/2018

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: 03/18/2018
• Distributor Facility Aware Date: 12/16/2016
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/18/2018
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 03/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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