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

Model Number G8

Device Problem Break (1069)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 01oct2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 operator's manual, chapter 5- filter replacement states the following: 5.7 filter replacement: replace the filter after 400 injections or when the pressure is more than what is indicated on the column inspection report + 4 mpa.1.Verify analyzer is in stand-by mode.If it is not press the stop key and wait until stand-by appears on the main screen.2.Open front door of the analyzer.A.Unscrew fitting and disconnect top tubing from filter holder assembly.B.Remove the top of the filter holder assembly by turning it counterclockwise.If salt crystals are present in the holder, rinse with deionized water to clean.C.Lightly press the top of the holder to remove the old filter element.D.Discard old filter.E.Install new filter (gray color in/white out).F.Firmly hand tighten top of filter holder assembly.G.Push outlet tubing until it extends ¼ inch past the end of the top fitting.H.Insert outlet tubing into filter holder assembly and screw fitting finger tight.3.From the second page of the main screen, press pump key to pump fluid.4.Check for leaks around the filter holder assembly.If a leak is detected, turn the pump off before attempting to tighten.5.Verify that the pressure stabilizes.The target pressure is within a range less than the column pressure which is indicated on the column inspection report +4 mpa.6.Press pump key to stop the pump.7.Close front door of the analyzer.8.Press mainte, reagent change, and then filter reset keys to reset the filter count.Press ok when the pop-up screen appears.The most probable cause of the reported event was due to operational error.

Event Description

The customer reported that the output side of the peek tubing fitting broke/cracked while attempting to replace the prefilter for their g8 analyzer.Technical support (ts) sent the customer a replacement peak tubing fitting and filter tubing line with fittings to be installed upon receipt.No further action was required by technical support.The reported event resulted in delay in reporting of patient result for hemoglobin a1c (hba1c).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: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• 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,
• MDR Report Key: 8075988
• MDR Text Key: 129310172
• Report Number: 8031673-2018-05265
• 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: 11/15/2018

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2018
• Distributor Facility Aware Date: 11/01/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/15/2018
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2010
• 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