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

Model Number G8

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491); Obstruction of Flow (2423)

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

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4)i 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).On (b)(6) 2016, fse arrived at the site to address the reported event.Fse removed line 6 from the injection valve and pressure dropped to zero.Then, he reconnected the tubing and removed the tubing at the bottom of the filter housing.Pressure subsequently began to increase.Fse wiped off end of tubing, restarted flow, reinstalled the filter tubing to the housing and finally stabilized at 7.51 mpa.The customer was subsequently able to run quality control (qc) without issue.The devise was determined to be functioning properly.No further action was required by field service.The most probable cause of the reported event was due to a clog at the junction of peek tubing inlet at the filter housing.

Event Description

On (b)(6) 2016, the customer reported high pressure errors with their g8 analyzer.Assessment of the device revealed that with the prefilter assembly disconnected and removed, the system pressure with the pump ran at greater than 11 mega pascals (mpa).Additionally, an obstruction was noted right before the prefilter housing on the input side.The customer further reported to technical support (ts) that they were now receiving low pressure errors.They denied any obvious leaks and stated that the filter was installed correctly.Ts assisted the customer to perform a drain flush and advised they wait ten minutes, then close the drain valve to bring the pressure up.On (b)(6) 2017, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; 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: 7368242
• MDR Text Key: 103789253
• Report Number: 8031673-2018-04242
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 03/23/2018
• Distributor Facility Aware Date: 06/16/2017
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/23/2018
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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