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

Model Number G8

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/09/2017

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) 2017, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse found that the left to x axis was off slightly.The fse adjusted the whole loader to the left.The fse also rerouted the needle tube.The fse ran patient samples with no z1 axis errors.The customer later stated that the error continued.The fse ran several tests and did not find an error.The fse found that the alignment was off for the y-sample.The fse made the adjustment and realigned the x1.The fse lubricated the z axis with triflow and ran patient samples with no z1 errors.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause for error 710 z1 axis was the xaxis needed an adjustment.

Event Description

On (b)(6) 2017, a customer reported error 710 z1 axis with the g8 analyzer.The customer is unable to run hba1c patient samples.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-723GA 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; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; ste. 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7365392
• MDR Text Key: 103725849
• Report Number: 8031673-2018-03586
• 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

• 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: 05/09/2017
• Device Age: 11 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• 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