MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8; G8, PRODUCT CODE: LCP

Model Number G8

Device Problem Bent (1059)

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

Event Date 12/24/2015

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted due to a retrospective review conducted under capa(b)(4).(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: the field service engineer (fse) was dispatched on (b)(6) 2015.The fse found a clog in the stator face assembly.The fse replaced with a new stator face and rotor seal and ran ten patients samples and controls to verify proper operation.Reportedly the quality controls and chromatograms looked good.The g8 was working as intended.No further action required by fse.The probable cause of the event was related to the stator face and rotor seal.

Event Description

On (b)(6) 2015 a customer reported a bent sample needle with their g8 analyzer.The customer was unable to run samples and requested service to address the reported event.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay reporting hba1c patient results.There was no indication of any patient intervention or adverse event consequence due to the delay of reporting patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8, PRODUCT CODE: LCP
• 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; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7315196
• MDR Text Key: 101842681
• Report Number: 8031673-2018-01440
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2018
• Distributor Facility Aware Date: 12/23/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/05/2018
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• 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