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

Model Number G8

Device Problem Decrease in Pressure (1490)

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

Event Date 12/13/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 a field service engineer (fse) was dispatched.When fse arrived, low pressure error came up again and valve 3 had no pressure.The fse replaced the valve 3 and primed but there was air in the line and fse found buffer 3 straw in bag curled up and too long.The fse primed all and ran patient samples to prime.Pressure was good with no errors.Preventive maintenance was done the following day.Low pressure problem was still there.The fse replaced the check valves; pressure came right up.Precision, calibrators, qc, etc.All were good and all passed within acceptable range.The g8 instrument was functioning as intended and errors cleared.The customer was able to resume operations.No further action was required by fse.The probable cause of the event was related to the check valves.A complaint history review for serial number (b)(4) was conducted from (b)(6) 2014 through (b)(6) 2015 for similar complaints.There were no similar complaints identified during the search period.(b)(4) is submitting on behalf of the foreign manufacturer tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).

Event Description

On (b)(6) 2015 a customer reported receiving low pressure error with the g8 analyzer.The customer is unable to run hbalc in the patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hbalc 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: 7310158
• MDR Text Key: 101694705
• Report Number: 8031673-2018-01811
• 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: 03/02/2018

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: 03/02/2018
• Distributor Facility Aware Date: 12/13/2015
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/02/2018
• Initial Date Manufacturer Received: 12/13/2015
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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