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

Model Number G8

Device Problems Material Separation (1562); Malposition of Device (2616)

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

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2015, fse arrived at the site to address the reported event.Visual inspection of the device determined that the glass was separating from the steel of the large syringe and that the readyne valve seal was not properly seated, resulting in high pressure.The large seal was replaced and corrected.The customer was subsequently able to successfully run calibration and controls.No further action was required by field service.The most probable cause of the reported event was due to fault/failure of the large syringe and misalignment of the readyne valve seal.

Event Description

On (b)(6) 2015, the customer reported hearing a grinding noise and receiving a "706 syringe-l error" with their g8 analyzer.Upon reboot and rerun, no peaks were detected.The sample needle had already been changed and buffer volumes were noted to be okay, but hemolysis wash was low and had been changed that morning.The customer reported that she had also primed and drained the flushes as a result of air in the lines above the sample needle.On (b)(6) 2015, a field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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: 7339616
• MDR Text Key: 102731167
• Report Number: 8031673-2018-02703
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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: 03/14/2018
• Distributor Facility Aware Date: 11/17/2015
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/14/2018
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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