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

Model Number G8

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived onsite to address the reported event.Fse located the tubing that had been displaced and rerouted it to the column; then verified the tubing was appropriately attached to ensure the issue did not recur.The customer ran four patient samples to verify the instrument was functioning correctly.No further issues were noted.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 07jul2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 2- connections, was reviewed.The g8 operator's manual indicates that: 2.6 column connection.The dedicated column for the tosoh automated glycohemoglobin analyzer hlc-723g8 is the tskgel g8 variant hsi.Never use the g8 column with any other instrument.Be sure to check for any damage to the package or packaging components before use.If any damage is observed, contact your local representative.Next, confirm that the following inserts are included with the column.· instructions for use 1.· inspection report 1.Chapter 2, column connection, under section 2.6 provides step-by-step instructions on the column connection procedure.The most probable cause of the reported event was due to disconnection & retraction of the column tubing.

Event Description

It was reported that the column tubing and ferrule had disconnected and retracted into the g8 analyzer and the column could not be installed.The customer requested service.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was 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
• 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 blvd; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7847878
• MDR Text Key: 120119885
• Report Number: 8031673-2018-00787
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• 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: 09/05/2018
• Distributor Facility Aware Date: 08/07/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/05/2018
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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