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

Model Number G8

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

A tosoh fse went to the customer site to evaluate the reported problem.The fse found that the customer was using tosoh white racks and replaced the white racks with sysmex beige 2.2 racks, installed long 12mm -13mm adapter rings to keep tubes from spinning, and adjusted the sample loader x1 path to the sample position, as they were binding.The fse replaced the sample needle with a vented needle, lubed the tube rollers and rack detent foot, and adjusted x and y positon of sample needle to center of tube.Following the fse ran ten (10) samples and all barcodes read.The fse verified proper operation of the g8 analyzer the reported problem was resolved by the fse and the g8 analyzer was returned to use.The most probable cause of the broken needle is related to improper seating of the sample tubes in the rack or misalignment of the sample needle.The g8 operator's manual was reviewed and indicates the following: 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.If you are using 12mm-14mm diameter primary tubes on a sysmex rack, make sure to attach a rack adapter to avoid the tubes from being too loose in the rack otherwise the sampling needle could be bent.If primary tubes with labels and those without labels are mixed together on the same rack, or when different types of primary tubes from different manufacturers are mixed on the same rack, make sure all the tubes are firmly held in place.If the tubes are excessively loose, prepare racks with different adapter diameters for each primary tube type if the needle becomes bent immediately after replacement, check that the primary tubes match the sample rack or sample rack adapter.If you are using 100 mm tubes, the finger guard must be removed.If the needle placement is clearly off center of the primary tube, it must be adjusted.Cancel the assay and contact technical support.(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).

Event Description

On (b)(6) 2016, the customer called tosoh technical support to report that they are trying to replace the sample needle for the g8 analyzer because it is bent.The customer further reported that the needle is in the down position and they are unable to raise up the needle as it is bent below the lucite block.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of patient results.There was no indication of 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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court, ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7312250
• MDR Text Key: 101703220
• Report Number: 8031673-2018-02215
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2018
• Distributor Facility Aware Date: 05/25/2016
• Device Age: 9 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/03/2018
• Date Manufacturer Received: 05/25/2016
• 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