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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A 13 month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 22-feb-2017 through aware date 22-mar-2018.There were no other similar complaints identified during the searched period.The g8 operator's manual under chapter 1 - introduction and applications, states the following: in chapter 5- maintenance procedures, under daily checklist states: be sure to check the following items before starting analysis: (1) column, the maintenance schedule is 2500 tests; (2) filter, maintenance schedule if 400 tests.Also in section 5.7 filter replacement, the guidance states: replace the filter in the following cases.When the filter counter reaches 400 injections.When the pressure is more than what is indicated on the column inspection report + 4 mpa.Firmly tighten the top of the filter holder assembly by hand until no further tightening is possible.After installing a new filter, reset (zero) the filter counter on the reagent change screen.Once the filter is tightened it will become deformed and cannot be used again.The most probable cause of the reported event could not be determined.Customer will wait for the time the preventive maintained is due.

Event Description

On (b)(6) 2018, a customer reported getting fluid leakage under the g8 instrument.Technical support specialist (tss) performed troubleshooting with the customer over the phone, but the issue did not resolve.The customer inquired for a preventive maintenance (pm) visit to resolve the issue.Later the same day, the customer reported the account decided not to have pm performed on the instrument until it's due for one.The event resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was 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
• 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: 7449604
• MDR Text Key: 106271603
• Report Number: 8031673-2018-00327
• 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: 04/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2018
• Distributor Facility Aware Date: 03/22/2018
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/21/2018
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2009
• 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