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

Model Number G8

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineer (fse) visited the customer to address the reported event.During evaluation, the fse found that the sampler belt had jumped teeth resulting in incorrect alignments.The customer was advised to use brown sysmex racks with 12mm tube adapters for best results with their vacutainer collection tubes.Fse then replaced the sample needle and aligned the rack sampling and stat sampling positions.The instrument was verified as operational.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 (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints found during the searched period the g8 operator's manual under chapter 5 maintenance procedures, 5.10 sampling needle replacement has a caution that states the following: replace the sampling needle if it is bent or broken.Use the following procedure to replace the sampling needle.Access to the inside of the analyzer is needed to replace the sampling needle.Be sure that only personnel who have been trained by tosoh or its representatives perform these operations.Be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during handling.Take care not to touch the end of the sampling needle during handling.If the needle placement is clearly off center of the primary tube, it must be adjusted.Cancel the assay and contact technical support.The most probable cause of the reported event was due to the sample y1 belt had skipped teeth causing the misalignment of the sample needle.

Event Description

The customer reported that the sample needle pierced the side of the tube and bent the needle on the g8 instrument.The customer changed the needle but wanted to find out if there was anything else that needed to be done.Technical support (ts) advised the customer to run a sample and observe the sample needle to ensure proper alignment into the middle of the sample stopper.However, when the customer called back, they reported that the sample needle was hitting the top side of the sample tube.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which 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: 7963721
• MDR Text Key: 126089673
• Report Number: 8031673-2018-00934
• 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: 10/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2018
• Distributor Facility Aware Date: 09/26/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/13/2018
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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