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 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a (b)(4) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.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, section 1.6 - procedures provides detailed information on column preparation and installation.In chapter 5: maintenance procedures, section 5.6 - column replacement provides detailed information on how to replace the column.The most probable cause of the reported event was due to a faulty column.

Event Description

On (b)(6) 2018, a customer reported getting calibration errors on the g8 instrument after replacing the column on (b)(6) 2018.Customer stated she primed and ran calibrators and the calibration failed.The customer made a second attempt and the calibration failed again.Customer tried to use their second instrument on site, switched the column, attempted calibrating and calibration failed.Customer had another new column, replaced column a second time and was able to calibrate and run controls successfully, all results were in acceptable range.This caused a delay in reporting of patient 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.Technical support specialist sent a replacement column to customer.The customer confirmed receipt of the new column on (b)(6) 2018.No further issues were reported.The g8 instrument is functioning as expected.

• 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7478487
• MDR Text Key: 107567776
• Report Number: 8031673-2018-00367
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• 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: 05/01/2018
• Distributor Facility Aware Date: 04/02/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2018
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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