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

Model Number G8

Device Problem Mechanical Jam (2983)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) contacted the customer over the phone to address the reported event.The customer reported that they found the screw and put it back on the top of the probe.They ran calibration and quality controls without any issues.The instrument was operating as expected.Upon follow up, the customer reported that they were running without any issues.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 01-oct-2017 through aware date (b)(4) 2018.There were no similar complaints found during this time.The g8 operator's manual under chapter 5 maintenance procedures under section 5.10 sampling needle replacement: open the left-side door and loosen two needle cover screws indicated in fig.5-11.You do not need to remove the screws.Open the door below the display and loosen one needle screw indicated in fig.5-11.Grasp the needle cover, push it inward while taking care not to break it, and remove it from the needle screw indicated in 3) above.Once you verify that the cover has been removed from the screws shown in fig.5-11, remove the cover by pulling it straightforward.You will see the sampling needle unit back in the middle.Grasp the upper part of the sampling needle unit by hand and slowly pull the unit forward as much as possible.Since a small volume of reagent will spill during replacement, place a lab wipe under the sampling needle tip.By hand, loosen and remove the joint connected to the 3-way block of the sampling needle flow line.Remove the screws on the upper section of the sampling needle.Be careful not to drop the screws or the holding plate inside the machine during this operation.See fig.5-12.Remove the tube from the black clip.The most probable cause of the reported event was due to operator error.

Event Description

The customer reported that they dropped a screw while changing the sample probe on the g8 instrument.The customer believed that the screw fell into the analyzer.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which could have resulted in delay of results for hemoglobin a1c (hba1c).There is 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 G8
• 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; 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: 8082029
• MDR Text Key: 129315610
• Report Number: 8031673-2018-05267
• 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: 11/16/2018

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: 11/16/2018
• Distributor Facility Aware Date: 11/01/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2010
• 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