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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

A 13-month complaint history review and service history review for serial number (b)(4)from 01-mar-2017 through aware date 30-mar-2018 for similar complaints was performed.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: when replacing the column, run at least three whole blood samples to prime the column then recalibrate the system before running quality control materials.Under chapter 2, pre-installation, the operator's manual states: 2.6 column connection the dedicated column for the tosoh automated glycohemoglobin analyzer (b)(4) 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.The most likely cause of the reported event was due to a faulty column.(b)(4).

Event Description

On (b)(6) 2018, a customer reported that after replacing the column calibration failed on the g8 instrument.The customer tried calibration again and ran some patient samples, which had been run on another g8 instrument and reported out of the lab, to compare results and were lower with the new column.The customer placed the old column back on the g8 instrument and ran calibration and quality controls and obtained acceptable results.The technical support specialist (tss) sent a new column to the customer, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).On (b)(6) 2018, the customer reported that after installing a new column all results were within acceptable range.No further action was required.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 105-8 623; JA 105-8623
• 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; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7463354
• MDR Text Key: 107092665
• Report Number: 8031673-2018-00355
• 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: 04/25/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2018
• Distributor Facility Aware Date: 03/30/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2018
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• 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