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

Model Number G8

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).On (b)(6) 2018, fse arrived at the site to address the reported event.Fse made adjustments to the x1 pusher foot, creating appropriate tension on the tube when placed in the sample position.The adjustments made the position of the tube more consistent and always aligned to the center of the tube.Fse also sent replacement needles to customer for future use.Proper equipment functionality was verified by running two racks of patient samples and quality control (qc).No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 service manual chapter 4 & 6 - assay operations & machinery was reviewed.The g8 service manual under chapter 6-assay operations & machinery indicates that: if the needle is bent immediately after replacement, check that the primary tubes match the sample rack or sample rack adapter.If the needle placement is clearly off-center of the primary tube, it must be adjusted.Change the "y-smp" parameter.Refer to page 4-16.If the primary tubes are loose on the tosoh rack, adjust the rack's holder to tightly hold the primary tubes.The sampling needle could be bent if the tubes are loose.Insert the primary tubes straight into the racks.If the primary tube is not set straight or its bottom is not fit to the rack, the sampling needle could be bent.The most probable cause of the reported event was due to sample needle misalignment.

Event Description

On (b)(6) 2018, the customer reported a bent sample needle with their g8 analyzer.The customer reported that the sample needle went through the side of the hemaguard cap and then bent the sample needle.The customer replaced the sample needle and the analyzer was back up and running; however, now they reported the sample needle has been randomly piercing the plastic portion of the caps instead of the rubber center section.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4) per exemption number e2017013.

• 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
• MDR Report Key: 7478577
• MDR Text Key: 107691869
• Report Number: 8031673-2018-00399
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

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: 07/05/2018
• Distributor Facility Aware Date: 06/25/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/05/2018
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1