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

Model Number G8

Device Problems Computer Software Problem (1112); Pressure Problem (3012)

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

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 a field service engineer (fse) was dispatched to address the reported event.The fse called the customer to troubleshoot the issue.The fse instructed the customer to reload the software from the flash card that was onsite then to drain, flush and run the pump while opening the drain valve.The customer ran controls with good results which resolved the issue and all errors cleared.The g8 analyzer was functioning as intended.No further action required by field service.The probable cause of the event was related to software corruption and a blocked drain valve.A complaint history review for (b)(4) was conducted from (b)(6) 2015 through (b)(6) 2016 for similar complaints.There were no similar complaints identified during the search period.(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 the system was not loading with the g8 analyzer.A field service engineer (fse) was dispatched.The customer is unable to run hbaic patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hbaic patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: TOSOH HLC-723G8 ANALYZER 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: 7321356
• MDR Text Key: 101996759
• Report Number: 8031673-2018-01830
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2018
• Distributor Facility Aware Date: 02/09/2016
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/07/2018
• Date Manufacturer Received: 02/09/2016
• 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