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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the event.During servicing, fse verified that the needle was bent and removed it.Fse installed a new sample needle and verified needle alignments.Fse inspected the rack holding the sample needle when the needle bent and found that the springs holding the tubes were weak and not keeping the tube straight.The customer ordered new racks.Fse then ran whole blood samples and quality controls with acceptable results.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 19-nov-2017 through aware date (b)(4) 2018.There was one (1) other similar complaint 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 weak springs on the sampling rack.

Event Description

The customer reported that the sample needle was bent after hitting the side of the tube on the g8 instrument.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: 8229666
• MDR Text Key: 133935090
• Report Number: 8031673-2018-05416
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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: 01/08/2019
• Distributor Facility Aware Date: 12/19/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/08/2019
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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